White Chocolate; Proposal to Establish a Standard of Identity

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