[Federal Register Volume 62, Number 46 (Monday, March 10, 1997)]
[Proposed Rules]
[Pages 10781-10786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5734]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 163
[Docket Nos. 86P-0297 and 93P-0091]
White Chocolate; Proposal to Establish a Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
establish a standard of identity for white chocolate. The proposed
standard will provide for the use of the term ``white chocolate'' as
the common or usual name of products made from cacao fat, milk solids,
nutritive carbohydrate sweeteners, and other safe and suitable
ingredients, but containing no nonfat cacao solids. This action
responds principally to citizen petitions submitted separately by the
Hershey Foods Corp. (Hershey) and by the Chocolate Manufacturers
Association of the United States of America (CMA). FDA tentatively
concludes that this action will promote honesty and fair dealing in the
interest of consumers and, to the extent practicable, will achieve
consistency with existing international standards of identity for white
chocolate.
DATES: Written comments by May 27, 1997. The agency proposes that any
final rule that may be issued based upon this proposal become effective
January 1, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 5, 1992 (57 FR 23989), FDA
published a
[[Page 10782]]
tentative final rule (hereinafter referred to as the 1992 tentative
final rule) to amend the standards of identity for cacao products in
part 163 (21 CFR part 163). In section II.B. of the 1992 tentative
final rule, FDA noted that it had received a comment that requested
that the agency adopt a standard of identity for white chocolate. In
support of that request, the comment argued that the absence of a
standard of identity for this food had limited the introduction of
``white chocolate'' products into the market. The comment also noted
the likelihood that consumer confusion would develop about the content
of products informally referred to as ``white chocolate'' that may or
may not contain any cacao-derived ingredients.
The comment observed that, in the absence of a standard of identity
for this product, the term ``white chocolate'' would be prohibited
under the existing standards of identity in part 163. Further, the
comment stated that when such products have been introduced, firms have
been forced to use alternative names to avoid the labeling constraints
in the standards of identity.
In response to the comment, FDA recognized the dilemma faced by
U.S. manufacturers of those confections that may be labeled ``white
chocolate'' in other countries but stated that the adoption of a
standard of identity for white chocolate was outside the scope of that
rulemaking. The agency suggested that the manufacturer petition the
agency to adopt a standard for this food. FDA pointed out that, in
fact, in the Federal Register of September 16, 1991 (56 FR 46798), the
agency had granted Hershey a temporary marketing permit (TMP) to test
market a product called ``white chocolate.'' The permit provided for
the temporary market testing of 23,608 kilograms (kg) (52,000 pounds
(lb)) of the product for a period of 15 months.
Since publication of the 1992 tentative final rule, the agency has
received several applications from chocolate manufacturers for TMP's
for ``white chocolate.'' In the Federal Register of November 5, 1993
(58 FR 59050), the agency granted Hershey a new TMP for test products
designated as ``white chocolate.'' The purpose of the new permit was to
permit Hershey to collect data on consumer acceptance of the product
over a wider area of distribution. Hershey said that it intended to use
these data to support its citizen petition (filed December 15, 1992,
Docket No. 86P-0297/CP2) (hereinafter referred to as the 1992 Hershey
petition) for a standard of identity for white chocolate. In the
November 5, 1993 notice, the agency announced that it had received a
citizen petition from CMA (filed March 2, 1993, Docket No. 93P-0091)
(hereinafter referred to as the 1993 CMA petition) that also requested
that FDA establish a standard of identity for white chocolate.
In addition to Hershey, the agency has granted TMP's to Ganong
Bros., Ltd., St. Stephen NB, Canada E3L 2X5 (58 FR 59050, November 5,
1993), the Pillsbury Co. (59 FR 32443, June 23, 1994), and Kraft
General Foods, Inc. (59 FR 33976, July 1, 1994).
In the Federal Register of December 29, 1994 (59 FR 67302), FDA
published a notice extending Hershey's TMP (Docket No. 93P-0310) and
inviting interested persons to participate in the extended market test
under the same conditions that applied under that TMP. Since January
1995, FDA has issued letters to The Proctor and Gamble Co., Brach and
Brock (formerly E. J. Brach Corp.), Mauna Loa Macadamia Nut Corp.,
Nestle Food Co., Kraft General Foods, MacFarms of Hawaii, Van Leer
Chocolate Corp., and Wilbur Chocolate Co. acknowledging the firms'
acceptance of the agency's invitation to participate in the extended
market test of products identified as being or containing white
chocolate. The aggregate effect of these TMP's is that up to 75 million
kg (166 million lb) per annum of product consisting, in large part, of
white chocolate has been, or will be, market tested. The majority of
the firms are conducting nationwide market tests. The agency is
currently evaluating requests from other firms to participate in the
extended market test.
II. Petitions and Grounds
A. The 1992 Hershey Petition
Hershey, in its 1992 petition requesting that FDA establish a
standard of identity for white chocolate, described the product named
``white chocolate'' as a food that deviates from the standardized cacao
products in part 163 in that: (1) It is prepared without the nonfat
components of the ground cacao nibs but contains the fat (cocoa butter)
expressed from the ground cacao nibs; and (2) it may contain safe and
suitable antioxidants. The petition further described ``white
chocolate'' as the solid or semiplastic food prepared by mixing and
grinding cocoa butter with one or more nutritive sweeteners and one or
more of the optional dairy ingredients provided in part 163. It
contains not less than 20 percent cocoa butter, not less than 14
percent of total milk solids, not less than 3.5 percent milkfat, and
not more than 55 percent nutritive carbohydrate sweeteners. It may
contain emulsifying agents, spices, natural and artificial flavorings
and other seasonings, and antioxidants approved for food use. It
contains no coloring material.
In support of its request, Hershey contended that, because there is
currently no standard of identity for white chocolate, virtually all
uses of the term ``white chocolate'' would be prohibited by the
existing standards of identity for chocolate because they prescribe the
presence of chocolate liquor (ground cacao nibs). Hershey argued that
this requirement has acted as a practical deterrent to companies that
have considered developing and marketing white chocolate products in
the United States. The Hershey petition noted that when such products
have been introduced and marketed in the United States, manufacturers
have had to resort to labeling such products with descriptive terms
other than ``white chocolate'' (e.g., ``white confection'') to avoid
standardized food labeling issues. Hershey contended that, in many
cases, the use of such alternative terminology has obscured the true
nature of the product and could potentially mislead consumers.
Therefore, Hershey maintained that the absence of a standard of
identity for white chocolate, and the resulting uncertainty over
nomenclature on labeling, have proven to be factors limiting the
introduction of new products to meet consumer demand.
In further support of its petition, Hershey maintained that there
exists a good likelihood of consumer confusion with regard to the
content of products that are referred to informally as ``white
chocolate'' but that may or may not contain any cacao-derived
ingredients. According to Hershey, consumers expecting to purchase a
white chocolate product may, in fact, be purchasing a vegetable fat
coating-type product made from fats other than cacao fat, which may
contain little or no cacao ingredients.
The Hershey petition also included a summary of the results of a
consumer survey conducted in 1990 to determine the most common name
used by adult candy consumers when shown a variety of confection
products, including a white confection bar. The survey was conducted by
personal interviews with 216 adults who eat candy regularly. After an
introductory statement on how people use different names for the same
product, respondents were shown a product and asked what they would
call it. The procedure was repeated for two or more products--jelly
beans, lollipops, and a white confection bar. Over 61 percent of the
respondents used the term ``white chocolate'' to describe
[[Page 10783]]
the white confection bar that they were shown. An additional 10 percent
of the respondents associated the bar product to chocolate. Hershey
contended that, based on these results, it appears that the majority of
candy consumers tend to identify the white confection as either ``white
chocolate'' specifically or as some variety of chocolate.
Hershey pointed out that many countries that have adopted standards
for cacao products have also recognized and established a standard of
identity for white chocolate. Hershey argued that, in countries that
have established a standard of identity for white chocolate, in
contrast to the United States, consumers are able to evaluate the
quality and value of the white chocolate products they purchase without
having to resort to an analysis of the product ingredient declaration.
Hershey maintained that establishing a U.S. standard of identity
for white chocolate would promote honesty and fair dealing in the
interest of consumers and build consumer confidence in the food supply
by establishing minimal criteria for a class of products that is
becoming popular with consumers. According to Hershey, adoption of the
suggested standard of identity for white chocolate will also enhance
the ability of American manufacturers to compete in world markets.
Hershey maintained that a U.S. standard will result in greater
consistency in the international regulation of cacao products, while
ensuring that domestic consumers are buying and consuming ``the real
thing.''
B. The 1993 CMA Petition
In all substantive respects, the 1993 CMA petition agrees with the
1992 Hershey petition. In support of its request for a white chocolate
standard, CMA noted that the standards of identity for cacao products
permit only those products that contain a minimum level of chocolate
liquor to be identified as chocolate. CMA maintained that, because
there exists a product that consumers identify as ``white chocolate,''
it is essential that the industry define this product, and that FDA
establish and enforce a standard of identity for white chocolate
products to avoid economic deception and promote honesty and fair
dealing in the interest of consumers.
Like Hershey, CMA contended that consumers are being presented with
products that often contain low levels of cocoa butter (if any at all)
and relatively high levels of noncacao vegetable fats which, except for
coatings made with vegetable fats, are not permitted in standardized
chocolate products. CMA further stated that products that identify
themselves as ``white chocolate,'' but that do not meet CMA's suggested
standard, represent a true deception of the consumer. According to CMA,
consumer deception distorts individual purchasing decisions and
prevents consumers from satisfying their product preferences. CMA
asserted that FDA can reduce or prevent the continuation of such
deception by establishing a standard of identity for white chocolate.
CMA further maintained that the absence of a standard of identity
for white chocolate denies consumers the benefit of knowing that a
white chocolate-type product that they purchase is, indeed, a true
cacao product. In the absence of such a standard, the U.S. chocolate
industry is unable to provide consumers with an identifiable white
chocolate product that meets both their expectations and the industry's
definition of quality.
CMA stated that the adoption of their suggested standard would have
a positive effect on the marketability of, and competition among,
chocolate products. CMA also acknowledged the submission to FDA of a
similar petition by Hershey and noted that CMA's suggested white
chocolate standard of identity is generally consistent with that in the
Hershey petition. CMA further noted that while its suggested standard
is generally based on FDA standards of identity for cacao products, the
specific minimum levels of cacao fat, milkfat, and total milk solids
are based on those found in the European Union (EU) white chocolate
standard published in the Official Journal of European Communities.
CMA explained that although antioxidants are not permitted in cacao
products under the current standards of identity for these foods, they
are needed in the proposed white chocolate standard. CMA maintained
that in making white chocolate, cocoa butter is typically deodorized to
achieve the desired flavor. In the process, the natural antioxidants
are removed. Therefore, CMA contended, the addition of antioxidants to
white chocolate is necessary to preserve the product flavor.
CMA suggested that because Canada is proposing a standard for white
chocolate that is also based on the EU standard, adoption of its
proposed standard would increase harmonization of U.S. requirements
with those of Canada. Such harmonization, CMA maintained, is consistent
with the goals of the North American Free Trade Agreement.
III. The Proposal
Both petitioners agree that a standard of identity for white
chocolate would promote honesty and fair dealing in the interests of
consumers, eliminate a deterrent to firms introducing new products,
enhance international marketability of the product, and be consistent
with the white chocolate standard of the EU and that proposed by
Canada.
The agency finds merit in the petitioners' request and tentatively
concludes that creating a standard of identity for white chocolate
would promote honesty and fair dealing in the interests of consumers
because the standard would eliminate the potential for economic fraud
and consumer deception through the substitution of cheaper ingredients
for cacao-derived ingredients.
Establishing a standard of identity for white chocolate will
alleviate the need for companies to request TMP's to market products
bearing the name ``white chocolate'' that deviate from the standards of
identity for other chocolate products or, in lieu of requesting a TMP,
crafting identity statements using descriptive names other than
``chocolate.'' A standard also will enhance international marketability
of the product and increase harmonization with the EU and Canada.
While the agency tentatively agrees with the petitioners that a
standard for white chocolate should be established, it notes that it is
reviewing its existing standards of identity in response to the
Administration's Regulatory Reinvention Initiative that seeks to
streamline Government to ease the burden on regulated industry and
consumers. In the Federal Register of December 29, 1995 (60 FR 67492),
FDA published an advance notice of proposed rulemaking (ANPRM) in which
it requested comments on whether food standards of identity should be
retained, revised, or revoked. In the ANPRM, the agency specifically
asked for comments on whether, if it institutes a broad rulemaking on
reinventing food standards, it is appropriate in the interim to have a
moratorium on food standard actions, i.e., on the issuance of TMP's and
on the development of new or revised food standard regulations. Several
comments submitted by industry to the ANPRM opposed a moratorium on the
creation of new standards of identity while the agency is reviewing
existing food standards in response to the Regulatory Reinvention
Initiative. The comments asserted that a moratorium would disadvantage
firms by delaying the introduction of new products and would not be in
the consumer's best interest.
[[Page 10784]]
Although FDA is reviewing existing food standards in response to
the Regulatory Reinvention Initiative, the agency tentatively concludes
that there are compelling reasons to establish a standard for white
chocolate at this time. First, the number of requests for TMP's for
white chocolate has demonstrated to the agency that there is a consumer
demand for this product. As discussed in section I. of this document,
the agency has granted TMP's for the market testing of up to 166
million lb of product containing white chocolate. Second, the
establishment of a standard for white chocolate seemingly will benefit
industry by making it easier to introduce new products containing white
chocolate. It will eliminate the need for firms to obtain a TMP to
market the products and to send labels to the agency for review
whenever they wish to market a new product containing white chocolate
or a different size product than those allowed by their TMP. Third, as
stated above, the establishment of the standard will benefit U.S. firms
by enhancing the international marketability of their product. Finally,
the adoption of a standard will ease FDA's burden because it will end
the flow of paper from firms seeking, or operating under a TMP. Thus,
the agency tentatively concludes that establishing a standard of
identity for white chocolate will be beneficial to consumers and to
industry and will also result in more efficient use of the agency's
limited resources.
However, FDA advises that if a standard of identity for white
chocolate is established, the agency will review it along with all
other standards of identity as part of the Regulation Reinvention
Initiative. The standard of identity for white chocolate would be
retained, revised, or revoked consistent with decisions regarding other
standards of identity for cacao products.
The proposed standard of identity for white chocolate is slightly
different from the standards of identity for other chocolate products
in part 163. As described in the 1993 CMA petition, safe and suitable
antioxidants are needed to help preserve the product's flavor. The
agency has no information that shows that the addition of safe and
suitable antioxidants to this product should be prohibited. Therefore,
FDA is proposing to provide for the use of antioxidants in proposed
Sec. 163.124(b)(5).
FDA tentatively concludes that it is reasonable to establish the
term ``white chocolate'' as the common or usual name for the
standardized food described below. The public has become familiar with
the term ``white chocolate'' through the recent market testing of
products that consist, in whole or in part, of this food. The agency
further tentatively concludes that use of this term will aid consumer
recognition of the food and will promote honesty and fair dealing in
the interest of consumers by eliminating the potential for economic
fraud and consumer deception through the substitution of cheaper
ingredients for cacao-derived ingredients. Finally, the agency
tentatively concludes that the consumer confusion engendered by the use
of alternative names for white chocolate-type confections will also be
eliminated, and that the use of the standardized term ``white
chocolate'' in the product name will enhance the international
marketability of such products.
Therefore, the agency is proposing to revise part 163 by
establishing a standard of identity for white chocolate in new
Sec. 163.124. Specifically, FDA is proposing to provide that ``white
chocolate'' have the following description:
1. White chocolate is the solid or semiplastic food prepared by
intimately mixing and grinding cacao fat with one or more of the
optional dairy ingredients and one or more optional nutritive
carbohydrate sweeteners and may contain one or more of the other
optional ingredients specified in the standard. White chocolate shall
be free of coloring material.
2. White chocolate shall contain not less than 20 percent by weight
of cacao fat, not less than 3.5 percent by weight of milkfat, not less
than 14 percent by weight of total milk solids, and not more than 55
percent by weight nutritive carbohydrate sweetener.
3. White chocolate may contain the following optional ingredients:
a. Nutritive carbohydrate sweeteners;
b. Dairy ingredients:
i. Cream, milkfat, butter;
ii. Milk, dry whole milk, concentrated milk, evaporated milk,
sweetened condensed milk;
iii. Skim milk, concentrated skim milk, evaporated skim milk,
sweetened condensed skim milk, nonfat dry milk;
iv. Concentrated buttermilk, dried buttermilk; and
v. Malted milk;
c. Emulsifying agents, used singly or in combination, the total
amount of which does not exceed 1 percent by weight;
d. Spices, natural and artificial flavorings, ground whole nut
meats, ground coffee, dried malted cereal extract, salt, and other
seasonings that do not either singly or in combination impart a flavor
that imitates the flavor of chocolate, milk, or butter; or
e. Antioxidants.
IV. Effective Date
To allow companies time to make any mandatory changes, the agency
proposes that any final rule that may be issued based on this proposal
become effective January 1, 1998. The final rule would apply to
affected products initially introduced or initially delivered for
introduction into interstate commerce on or after the effective date.
V. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select the regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). Executive
Order 12866 classifies a rule as significant if it meets any one of a
number of specified conditions, including having an annual effect on
the economy of $100 million, adversely affecting in a material way a
sector of the economy, competition, or jobs, or raising novel legal or
policy issues. If a rule has a significant impact on a substantial
number of small entities, the Regulatory Flexibility Act requires
agencies to analyze options that would minimize the economic impact of
that rule on small entities. FDA finds that this proposed rule is not a
significant rule as defined by Executive Order 12866. The agency
acknowledges that under some circumstances this proposed rule may have
significant impact on a substantial number of small entities. It has
been determined that this rule is not a major rule for the purpose of
congressional review (Pub. L. 104-121).
A. Alternatives
FDA is proposing to establish a standard of identity for white
chocolate so that only products meeting the criteria described in the
proposal may be called ``white chocolate.'' One alternative is to not
establish a standard and allow manufacturers to market products bearing
the name ``white chocolate'' only with TMP's. Another alternative is to
establish a standard for white chocolate that is consistent with the
standard described in the petitions where the levels of the ingredients
are prescribed. A third alternative is to establish a standard of
identity for white
[[Page 10785]]
chocolate with different criteria than those proposed in the petitions.
While the agency has no explicit information on the exact formulations
or attributes that consumers associate with the term ``white
chocolate,'' the agency has written the proposed standard of identity
to be as consistent as possible with the existing standards of identity
for chocolate products while making the necessary allowances to
accommodate the formulations described in the petitions. FDA requests
comments on these and other alternatives to the proposed standard of
identity.
B. Benefits
The largest benefit of this proposed standard of identity for white
chocolate is that it will eliminate a manufacturer's need to prepare
and submit requests for TMP's in order to market products bearing the
name ``white chocolate.'' Another benefit is that it would eliminate
the need to divert scarce agency resources to the evaluation of these
TMP requests. Currently, manufacturers are required to obtain TMP's to
use the term ``chocolate'' to market products that meet the proposed
standard because they deviate from the existing standards of identity
for chocolate products. The agency has received more than 1 dozen
requests for TMP's for white chocolate in the last year. The
establishment of the proposed standard of identity would save hours of
manufacturer and FDA time required for the preparation and evaluation
of each TMP.
Additionally, the benefits usually attributed to the establishment
of standards of identity are reductions in the potential for consumer
confusion and deception. Well defined standards of identity, which
establish consistent product names, can assist consumers in finding and
comparing products by the name of the food. Finally, the proposed
standard will establish a new product name that, according to the
petitions, is consistent with the name that a majority of consumers are
already using to describe this product.
C. Costs
The establishment of a standard of identity requires that all
products that meet the standard bear the standardized name. If there
are products that are formulated in accordance with the proposed
standard but are not currently marketed under a TMP allowing use of the
term ``white chocolate,'' then those products will have to be
relabeled. Because ``white chocolate'' will need to appear on each
product's principal display panel, the cost for label changes will
depend on the number of products needing to be relabeled and the amount
of time manufacturers are given to complete the label changes. The
actual cost of relabeling will be determined largely by the length of
time between the date that the proposed rule becomes final and the
effective date of the final rule (the compliance period). In general,
the large chocolate manufacturers are already marketing their products
under TMP's. For small firms the cost of relabeling ranges from $12,750
with a 6-month compliance period to $1,550 with a 24-month compliance
period. The agency has no information on the number of products that
will need to be relabeled. There are approximately 250 firms that
produce chocolate products in the United States, however, the number of
products that meet the proposed standard of identity is unknown. This
proposal will not affect products that do not meet the standard,
because they may continue to be produced and marketed as they currently
are. FDA is not able to estimate the total cost of this proposal and
requests that comments supply information on this issue.
D. Initial Regulatory Flexibility Analysis
If finalized, this proposed rule will establish a standard of
identity for white chocolate. Depending upon the length of the
compliance period, this proposal may or may not impose significant
compliance costs on industry and there may or may not be a significant
impact of these provisions on a substantial number of small businesses.
However, because there is some uncertainty related to the costs of
compliance, FDA is voluntarily doing this Initial Regulatory
Flexibility Analysis. The agency requests comment on this judgment.
FDA believes that the only provision of this proposed rule that may
have a significant impact on a substantial number of small businesses
is related to the compliance period. There are approximately 250 firms
that produce chocolate products (Standard Industry Classification Code
206603) in the United States. Almost all of these businesses have fewer
than 500 employees. The agency has no data on the number of products
that will meet the proposed standard and that, therefore, may need to
be relabeled. The relabeling costs are the primary costs of the rule.
Relabeling costs vary inversely to the length of the compliance period.
FDA has estimated the compliance costs based on three alternatives for
the length of the compliance period.
With a 6-month compliance period the costs to small firms that
produce one product that would meet the proposed standard are estimated
to be $12,750 ($3,400 for administrative costs, $3,200 for printing
costs, and $6,150 for costs of lost label inventory). With a 12-month
compliance period the costs to small firms that produce one product
that would meet the proposed standard are estimated to be $3,300
($1,700 for administrative costs, $1,100 for printing costs, and $500
for costs of lost label inventory). With a 24-month compliance period
the costs to small firms that produce one product that would meet the
proposed standard are estimated to be $1,550 ($850 for administrative
costs, $700 for printing costs, and nothing for costs of lost label
inventory). The agency requests comments on the impact of the
compliance period on small chocolate producers and suggestions for
minimizing the impact of this proposed rule on small businesses.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(b)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling, or other third party disclosure
requirements. Thus, there is no ``information collection''
necessitating clearance by the Office of Management and Budget.
However, to ensure the accuracy of this tentative conclusion, FDA is
asking for comment on whether this proposed rule imposes any paperwork
burden.
VIII. Comments
Interested persons may, on or before May 27, 1997, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 163
Cacao products, Food grades and standards.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to
[[Page 10786]]
the Director, Center for Food Safety and Applied Nutrition, it is
proposed that 21 CFR part 163 be amended as follows:
PART 163--CACAO PRODUCTS
1. The authority citation for 21 CFR part 163 continues to read as
follows:
Authority: Secs. 201, 301, 401, 403, 409, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 341, 343,
348, 371, 379e).
2. New Sec. 163.124 is added to subpart B to read as follows:
Sec. 163.124 White chocolate.
(a) Description. (1) White chocolate is the solid or semiplastic
food prepared by intimately mixing and grinding cacao fat with one or
more of the optional dairy ingredients and one or more optional
nutritive carbohydrate sweeteners and may contain one or more of the
other optional ingredients specified in paragraph (b) of this section.
White chocolate shall be free of coloring material.
(2) White chocolate contains not less than 20 percent by weight of
cacao fat as calculated by subtracting from the weight of the total fat
the weight of the milkfat, dividing the result by the weight of the
finished white chocolate, and multiplying the quotient by 100. The
finished white chocolate contains not less than 3.5 percent by weight
of milkfat and not less than 14 percent by weight of total milk solids,
calculated by using only those dairy ingredients specified in paragraph
(b)(2) of this section, and not more than 55 percent by weight
nutritive carbohydrate sweetener.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Nutritive carbohydrate sweeteners;
(2) Dairy ingredients:
(i) Cream, milkfat, butter;
(ii) Milk, dry whole milk, concentrated milk, evaporated milk,
sweetened condensed milk;
(iii) Skim milk, concentrated skim milk, evaporated skim milk,
sweetened condensed skim milk, nonfat dry milk;
(iv) Concentrated buttermilk, dried buttermilk; and
(v) Malted milk;
(3) Emulsifying agents, used singly or in combination, the total
amount of which does not exceed 1 percent by weight;
(4) Spices, natural and artificial flavorings, ground whole nut
meats, ground coffee, dried malted cereal extract, salt, and other
seasonings that do not either singly or in combination impart a flavor
that imitates the flavor of chocolate, milk, or butter; or
(5) Antioxidants.
(c) Nomenclature. The name of the food is ``white chocolate'' or
``white chocolate coating.'' When one or more of the spices,
flavorings, or seasonings specified in paragraph (b)(4) of this section
are used, the label shall bear an appropriate statement, e.g., ``Spice
added'', ``Flavored with __________'', or ``With __________ added'',
the blank being filled in with the common or usual name of the spice,
flavoring, or seasoning used, in accordance with Sec. 101.22 of this
chapter.
(d) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections
of parts 101 and 130 of this chapter.
Dated: January 6, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-5734 Filed 3-7-97; 8:45 am]
BILLING CODE 4160-01-F