[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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