[Federal Register Volume 59, Number 177 (Wednesday, September 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22646]
[[Page Unknown]]
[Federal Register: September 14, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 135
[Docket No. 88P-0251]
Frozen Desserts: Removal of Standards of Identity for Ice Milk
and Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice
Cream and Frozen Custard and Goat's Milk Ice Cream
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to remove the standard of identity for ice milk; to amend
the standard of identity for ice cream and frozen custard to provide
for the use in these foods of safe and suitable sweeteners and of skim
milk that may be concentrated, and from which part or all of the
lactose has been removed by a safe and suitable procedure; and to amend
the standard of identity for ice cream and frozen custard to provide
for the optional use of hydrolyzed milk proteins as stabilizers in the
food at a level not to exceed 3 percent by weight to ice cream mix
containing not less that 20 percent total milk solids, provided that
any whey and modified whey products used contribute, singly or in
combination, not more than 25 percent by weight of the total nonfat
milk solids content of the finished food. To ensure consistency with
the removal of the standard of identity for ice milk and the changes in
the standard of identity for ice cream and frozen custard, FDA also is
removing the standard of identity for goat's milk ice milk and making
comparable changes in the standard of identity for goat's milk ice
cream, which cross-references the standard of identity for ice cream
and frozen custard. FDA finds that these actions will promote honesty
and fair dealing in the interest of consumers. FDA is also requiring
that all sweeteners other than nutritive carbohydrate sweeteners used
in these foods be declared as part of the name of the food. This
requirement will terminate after a period of 3 years. After that time,
the use of these sweeteners will only have to be reflected in the
ingredient statement for these products.
DATES: Effective September 14, 1995; written objections and requests
for a hearing by October 14, 1994. Compliance with this regulation may
begin on September 14, 1994.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Margaret E. Cole, 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 January 6, 1993 (58 FR 520), FDA
published a proposed rule: (1) To remove the standards of identity for
ice milk (Sec. 135.120 (21 CFR 135.120)) and goat's milk ice milk
(Sec. 135.125 (21 CFR 135.125)); and (2) to amend the standards of
identity for ice cream and frozen custard (Sec. 135.110 (21 CFR
135.110)) and, by cross-reference, goat's milk ice cream (Sec. 135.115
(21 CFR 135.115)) to provide for the use in these foods of safe and
suitable sweeteners and of skim milk that may be concentrated and from
which part or all of the lactose has been removed by a safe and
suitable procedure. The agency also requested information on the use of
other milk-derived protein ingredients such as milk protein
hydrolysates. Interested persons were given until March 8, 1993, to
comment.
II. Comments and the Agency's Responses
In response to the proposal, FDA received 46 letters, each
containing one or more comments from food companies, ingredient
suppliers, industry trade associations, State government agencies, and
consumers. All of the comments favored the removal of the standards of
identity for ice milk (Sec. 135.120) and goat's milk ice milk
(Sec. 135.125). One comment addressed an issue (i.e., the need for
uniformity in the size, style, and color of the type used in food
labeling) that is outside the scope of this proposal and that will not
be discussed here.
Several comments suggested modifications in, or were opposed to,
various provisions of the proposal to amend the standards of identity
for ice cream (Sec. 135.110) and, by cross-reference, goat's milk ice
cream (Sec. 135.115). A summary of these comments and the agency's
responses follow.
A. Safe and Suitable Ingredients
1. Sweeteners
FDA proposed (58 FR 520 at 523 and 524) to amend the standards of
identity for ice cream and, by cross-reference, goat's milk ice cream
to permit the use of safe and suitable sweeteners (Sec. 135.110(a)(1)
and Sec. 135.115(a)) as long as the presence of sweeteners other than
nutritive carbohydrate sweeteners is declared by their common or usual
name on the principal display panel of the label as part of the
statement of identity, and as long as the labeling of ice cream
products sweetened with such sweeteners complies with the applicable
provisions of Sec. 105.66 (21 CFR 105.66) (proposed Sec. 135.110(e)(7)
and proposed Sec. 135.115(c)(2)). The agency specifically requested
comments on the need for, and appropriateness of, these proposed
changes. The comments generally supported permitting alternative
sweeteners (safe and suitable sweeteners other than nutritive
carbohydrate sweeteners) in ice cream. Some comments, however,
questioned the proposed declaration requirements for alternative
sweeteners. These comments are addressed below.
1. Several comments opposed the requirement that the presence of
alternative sweeteners be declared in the statement of identity, as
provided in proposed Sec. 135.110(e)(7). These comments stated that the
existing regulations for the labeling of specific alternative
sweeteners adequately inform consumers of the presence of alternative
sweeteners in foods. These comments also expressed the view that there
is no need to establish special front panel labeling requirements for
alternative sweeteners in ice cream, and that such a requirement would
contribute to label clutter on products in which manufacturers use more
than one alternative sweetener in their formulation.
These comments noted that the proposed declaration requirement
singles out ice cream for special labeling that is not applied to other
standardized foods, and that such a requirement also singles out
alternative sweeteners for special labeling that is not applied to
other ingredients, including nutritive carbohydrate sweeteners. These
comments further argued that milk and dairy components, not sugar, are
the defining characteristics of ice cream. These comments expressed the
view that use of the name ``ice cream'' with a nutrient content claim
in the statement of identity, and the obligatory referral statement
that directs consumers to the information panel, would signal to
consumers that the product differs from the traditional standardized
food.
FDA proposed to require that alternative sweeteners be declared by
their common or usual name on the principal display panel of the label
as part of the statement of identity because of the agency's tentative
conclusion that ice cream sweetened with alternative sweeteners is a
distinctly different product than that sweetened with nutritive
carbohydrate sweeteners. The agency proposed this requirement to ensure
that ice cream sweetened with alternative sweeteners is clearly
distinguishable from the traditional food, and so that consumers who
want to avoid ice cream that contains alternative sweeteners will be
able to do so. In the proposal, the agency tentatively concluded that
it is necessary to inform consumers of the presence of alternative
sweeteners in ice cream under sections 201(n) and 403(a) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(n) and 343(a)).
Based on its consideration of the comments, the agency has
confirmed its view that consumers should be advised through labeling on
the principal display panel of the label or other labeling, including
restaurant menus and ice cream shop and parlor listings, when ice cream
products are made with sweeteners other than nutritive carbohydrate
sweeteners. Currently, such products are labeled as ``frozen desserts''
or by some other name that is not confusingly similar to the
standardized term ``ice cream.'' When the amendments to Secs. 135.110
and 135.115 set forth below become effective, products that differ from
traditional ice cream in that they contain alternative sweeteners would
be subject to being labeled simply as ``ice cream'' but for the
clarification of the differences between these products and traditional
ice cream that the agency has decided to require.
FDA does not agree that the existing regulations for the labeling
of specific alternative sweeteners adequately inform consumers of the
presence of these sweeteners in ice cream. It is true that
manufacturers must declare the presence of aspartame and of saccharin
in a food on the food label. The label of ice cream that contains
aspartame will have to bear either on the principal display panel or on
the information panel in a prominent and conspicuous manner the
statement: ``PHENYLKETONURICS: CONTAINS PHENYLALANINE,'' as specified
in Sec. 172.804(e)(2) (21 CFR 172.804(e)(2)). The label of ice cream
that contains saccharin will have to bear in a conspicuous place on
such label and labeling as proximate as possible to the name of such
food, the statement: ``USE OF THIS PRODUCT MAY BE HAZARDOUS TO YOUR
HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN DETERMINED TO
CAUSE CANCER IN LABORATORY ANIMALS,'' as specified in section 403(o)(2)
of the act (21 U.S.C. 343(o)(2)). In neither case, however, is there a
specific requirement that the statements appear on the principal
display panel of the ice cream label as is the case under
Sec. 135.110(f)(7) (proposed as Sec. 135.110(e)(7)). Further, there is
no legal or regulatory requirement for special labeling statements on
the principal display panel to inform consumers that ice cream contains
other alternative sweeteners (e.g., sorbitol, acesulfame K). Without
Sec. 135.110(f)(7), there need not be anything on the principal display
panel to call consumers' attention to the presence of alternative
sweeteners in ice cream. Thus, FDA finds that there would not be
adequate notice of the presence of these sweeteners without this
provision.
FDA does not agree that the declaration requirement singles out ice
cream sweetened with alternative sweeteners for special labeling. FDA
has established a number of standards of identity specifically for
artificially sweetened versions of traditional foods, such as canned
fruits, so that the artificially sweetened versions of these foods are
distinguishable from their traditional counterparts that are sweetened
with nutritive carbohydrate sweeteners. These artificially sweetened
versions of traditional foods are identified as such through label
declaration on the principal display panel.
As an example, the standard of identity in Sec. 145.170 (21 CFR
145.170) for canned peaches provides for the addition of safe and
suitable nutritive carbohydrate sweeteners (e.g., corn sirup, invert
sugar sirup, sugar, dried glucose sirup, or cane sirup) to the packing
medium. The name of this food is ``peaches'' as prescribed in
Sec. 145.170(a)(4). By contrast, the standard of identity in
Sec. 145.171 (21 CFR 145.171) for artificially sweetened canned peaches
conforms to the definition and standard of identity in Sec. 145.170 for
canned peaches except that it provides for the use of water
artificially sweetened with saccharin, with sodium saccharin, or with a
combination of both, as the packing medium. The name of this food is
``artificially sweetened peaches.''
Traditionally, sugar (or other nutritive carbohydrate sweeteners),
as well as milk and cream (or dairy products of equivalent
composition), defines the food known as ``ice cream.'' In establishing
the standard of identity for ice cream, the findings of fact (August 8,
1950, 15 FR 5112 at 5114) gave the following definition of ice cream:
Ice cream is the common and usual name of the frozen product
made from cream or a mixture of milk and cream (or a combination of
dairy products of equivalent composition), sweetened with sugar or
other suitable sweetening agent, and containing natural or imitation
flavorings or other food ingredients, such as cocoa, fruit, and
nuts, to characterize it as a kind of ice cream.
Although the findings of fact stated that sugar is the most common
sweetening agent in ice cream, the findings of fact also stated that a
number of other nutritive carbohydrate sweeteners (e.g., dextrose,
invert sugar, corn sirup, maple sirup, honey, brown sugar) are suitable
for sweetening ice cream.
Based on the foregoing, the agency believes that consumers have
traditionally understood that ``ice cream'' is a food that is sweetened
with nutritive carbohydrate sweeteners. The agency is adopting
Secs. 135.110(f)(7) and 135.115(c)(2) to ensure that consumers will be
able to distinguish the traditional food that is sweetened with
nutritive carbohydrate sweeteners from ice cream sweetened with
alternative sweeteners. The common or usual name of the latter food is
``ice cream sweetened with --------------------,'' the blank being
filled in with the common or usual name of any alternative sweeteners
used in the food.
FDA advises that, as a consequence of this action, modified ice
cream products made in conformance with the general definition and
standard of identity in Sec. 130.10 (21 CFR 130.10) that are named by
use of a nutrient content claim and the standardized term, and that
contain alternative sweeteners, must include the common or usual names
of these sweeteners in their statement of identity, e.g., ``reduced fat
ice cream sweetened with ----------------,'' the blank being filled
with the common or usual name of any alternative sweeteners used in the
food.
The agency finds that Secs. 135.110(f)(7) and 135.115(c)(2) will
provide for adequate notice to consumers that safe and suitable
sweeteners other than nutritive carbohydrate sweeteners are present in
the ice cream or goat's milk ice cream, and that the information
required under these provisions is necessary to allow consumers to make
informed purchasing decisions in the marketplace. Thus, FDA concludes
that this action will promote honesty and fair dealing in the interest
of consumers, and the agency is amending these regulations accordingly,
as set forth below.
FDA concludes, however, that labeling to distinguish ice cream
products sweetened with alternative sweeteners from those sweetened
with nutritive carbohydrate sweeteners will not be necessary after
consumers have become aware of the fact that some ice cream products
are made with nutritive carbohydrate sweeteners, and others with
alternative sweeteners, and have had a period of time to become
familiar with such foods. Thus, the regulations set out below
(Secs. 135.110(f)(7) and 135.115(c)(2)) only require that the name of
the alternative sweeteners be included as part of the name of the food
for 3 years following the effective date of the regulation. At the end
of 3 years, this requirement will terminate, and the presence of
alternative sweeteners will only have to be declared as part of the
ingredient list. FDA believes that 3 years is an adequate amount of
time for people to become aware that ``ice cream'' may be made with
either nutritive carbohydrate sweeteners or alternative sweeteners, and
thus that it is necessary to check the ingredient list. Three years
represented the amount of time necessary for ``canola oil'' to become
the accepted common or usual name for low-erucic acid rapeseed oil (see
50 FR 3755, January 21, 1985 and 53 FR 52652, December 29, 1988). Based
on this precedent, the agency finds that a similar amount of time is
appropriate here.
2. One comment objected to the proposed labeling requirement that
ice cream sweetened with alternative sweeteners be labeled to comply
with the requirements of Sec. 105.66.
In the proposal, FDA noted that foods that are sweetened with one
or more artificial sweeteners are foods for special dietary use under
Sec. 105.3(a)(2). The agency proposed in Sec. 135.110(e)(7) for ice
cream, and in Sec. 135.115(c)(2) for goat's milk ice cream, to require
that when these foods are sweetened with alternative sweeteners, they
must be labeled to comply with the requirements of Sec. 105.66 because
FDA anticipated that these foods would be represented for special
dietary use because of their usefulness in helping to reduce or
maintain body weight. Such foods must comply with the labeling
requirements of Sec. 105.66 (i.e., they must bear special labeling
statements such as ``low calorie'' and ``reduced calorie'').
FDA acknowledges that the requirements prescribed in Sec. 105.66
may not always apply to the labeling of ice cream sweetened with
alternative sweeteners. There may be instances in which ice cream
sweetened with alternative sweeteners will not purport to be, or will
not be represented to be, for special dietary use because of its
usefulness in reducing or maintaining body weight. For instance, a
manufacturer may replace all of the nutritive carbohydrate sweeteners
in ice cream with alternative sweeteners but not reduce the fat content
sufficiently for the food to be ``reduced calorie,'' or a manufacturer
may replace some of the nutritive carbohydrate sweeteners in ice cream
with alternative sweeteners but not reduce the level of nutritive
carbohydrate sweeteners sufficiently for the food to be ``reduced
calorie.'' Therefore, even though the ice cream is sweetened with
alternative sweeteners, it would not qualify for the use of terms such
as ``low calorie'' or ``reduced calorie'' or another comparative
caloric claim in compliance with part 101 because the manufacturer has
not reduced the fat or carbohydrate levels in the food sufficiently to
permit the use of such terms on the food label. The agency recognizes
that, in such instances, the food need not be labeled in compliance
with Sec. 105.66. However, in instances in which ice cream sweetened
with alternative sweeteners does purport to be, or is represented, for
special dietary use because of its usefulness in reducing or
maintaining weight, it must bear special label statements in accordance
with Sec. 105.66. If ice cream sweetened with alternative sweeteners is
represented for special dietary use because of its usefulness in the
diet of diabetics, the food must be labeled to comply with the
requirements of Sec. 105.67.
Therefore, to reflect these facts, FDA has revised proposed
Sec. 135.110(e)(7) (redesignated as Sec. 135.110(f)(7)) to delete the
statement that ice cream sweetened with safe and suitable sweeteners
other than nutritive carbohydrate sweeteners must be labeled to comply
with the requirements of Sec. 105.66 and to state instead: ``If the
food purports to be or is represented for special dietary use, it shall
bear labeling in accordance with the requirements of part 105 of this
chapter.'' In addition, the agency has made a similar revision to
Sec. 135.115(c)(2) for goat's milk ice cream.
3. One comment expressed concern that FDA would require ingredients
that are not found in traditional ice cream, such as safe and suitable
sweeteners other than nutritive carbohydrate sweeteners, to be
identified by an asterisk in the ingredient statement on the label of
ice cream in accordance with the general definition and standard of
identity in Sec. 130.10.
This comment is incorrect. In Sec. 130.10, FDA established
requirements for foods named by use of a nutrient content claim and a
standardized term. The comment specifically refers to the requirement
in Sec. 130.10(f)(2) that ingredients used to produce such a food, but
that are not provided for in the standard of identity for the
traditional food that the new food resembles, and for which it
substitutes, be identified with an asterisk in the statement of
ingredients. The agency is amending the ice cream standard in
Sec. 135.110(a)(1) to provide for the use of safe and suitable
sweeteners, both nutritive and nonnutritive, in ice cream. Thus, safe
and suitable sweeteners other than nutritive carbohydrate sweeteners
are now provided for in the standard of identity for ``ice cream.'' As
a result, Sec. 130.10(f)(2) does not apply to safe and suitable
alternative sweeteners, such as aspartame or acesulfame K, used in a
modified ice cream product. As a result, in making a ``reduced
calorie'' ice cream, manufacturers who replace some or all of the
nutritive carbohydrate sweeteners in the food with one or more safe and
suitable alternative sweeteners will not need to identify these safe
and suitable sweeteners with an asterisk in the ingredient statement on
the label of the modified product although they will need to identify
these sweeteners on the principal display panel for the next 3 years.
2. Dairy Ingredients
The standard of identity for ice cream (Sec. 135.110) provides for
the optional use of one or more of the specific dairy ingredients
listed in Sec. 135.110(b). In view of the wide range of optional dairy
ingredients listed by name or by the process by which they are derived
in Sec. 135.110(b), FDA invited comments on whether the specific names
should be deleted from Sec. 135.110(b), and whether the standard should
be amended to provide for the use of any safe and suitable dairy
ingredient (58 FR 520 at 525). In addition, the agency specifically
requested that any comments supporting the use of a collective term
such as ``dairy ingredient'' provide a definition for the term that
will facilitate proper interpretation of any regulation that may
result.
4. Several comments requested that FDA revise Sec. 135.110(b) to
provide for the use of any safe and suitable dairy ingredient. The
comments stated that the current list of specific optional dairy
ingredients unnecessarily limits the types of dairy ingredients that
may be used in ice cream products and impedes the development of
innovative technologies for the production of new ingredients for use
in ice cream products.
One comment suggested that the term ``dairy ingredient'' be defined
as an ingredient processed by any safe and suitable process from cow's
or goat's milk. Another comment merely stated that the definition of
``dairy ingredient'' should include ingredients that have the same
physical composition that occurs in natural milk, as well as
ingredients that have been modified physically but that have not been
substantially altered chemically.
In establishing the standard of identity for ice cream, the
findings of fact (15 FR 5112 at 5114) stated that ice cream is
essentially a sweetened milk and cream product, and that it is made
from cream, or a mixture of milk and cream (or a combination of dairy
products of equivalent composition) and sugar or other suitable
sweetening agent. The ice cream standard included a specific listing of
optional dairy ingredients that FDA considered to be suitable for use
in ice cream. These dairy ingredients were restricted to the following:
Cream, butter, milk, concentrated milk, evaporated milk, sweetened
condensed milk, dried milk, skim milk, concentrated (evaporated or
condensed) skim milk, superheated condensed skim milk, sweetened
condensed skim milk, dried skim milk, sweet cream buttermilk, condensed
sweet cream buttermilk, dried sweet cream buttermilk, and sweetened
skim milk which has been concentrated and from which part of the
lactose has been removed after crystallization. However, in
establishing the ice cream standard, FDA also recognized that certain
ingredients that were derived in part from milk, but that were no
longer equivalent in composition to milk, were not suitable for use in
ice cream because they were so changed that they had lost the
characteristics of milk and cream, including a large proportion of
their water-soluble vitamins and minerals (15 FR 5112 at 5115). Thus,
to ensure the integrity of ice cream, the agency did not provide for
the use of such ingredients in the food.
Since the standard of identity for ice cream was first published,
technological advances in the dairy industry have increased the number,
variety, and availability of ingredients derived from dairy sources.
These developments have made less and less obvious the boundary between
dairy ingredients and other ingredients that may be derived from dairy
sources but that are not dairy ingredients.
Over the years, the list of optional dairy ingredients permitted in
ice cream has gradually grown to include various forms of milk, skim
milk, cream, butter, and whey products, although there are certain
restrictions on the level of use of the last type of ingredients (i.e.,
any whey and modified whey products used can contribute, singly or in
combination, not more than 25 percent by weight of the total milk
solids content of the finished food (Sec. 135.110(b)). In addition, the
ice cream standard permits the optional use of caseinates with certain
restrictions on their levels of use in the food (i.e., they may be
added to ice cream mix containing not less than 20 percent total milk
solids (Sec. 135.110(c)), but FDA does not consider caseinates to be
dairy ingredients.
FDA finds that to ensure the integrity of ice cream, any definition
for the term ``dairy ingredient'' must differentiate between dairy
ingredients and other ingredients that may be derived from dairy
sources but that are not suitable as replacements for the milk solids
in ice cream, or that are suitable only when used in limited amounts
because they are no longer equivalent in composition to milk and cream.
In the manufacture of these dairy-derived ingredients such as
caseinates, changes are made that make them different from milk and
cream. For example, in making caseinates, the calcium normally present
in the naturally occurring casein of milk may be replaced with sodium.
In addition, if casein or caseinates alone are used to replace the
protein of milk, the protein quality of the ice cream may be decreased
because the protein efficiency ratio for whole milk protein is higher
than that for casein.
The definitions for ``dairy ingredient'' that were suggested by the
comments do not distinguish dairy ingredients from dairy-derived
ingredients. Without an adequate definition for this term, FDA is
hesitant to expand the list of optional ingredients permitted for use
in ice cream in Sec. 135.110(b) to allow for ``dairy ingredients''
because of the problems that use of the term will engender. Thus, the
agency is retaining the list of optional dairy ingredients that may be
used in ice cream and is not providing for the general category
designation of safe and suitable dairy ingredients in Sec. 135.110(b).
3. Milk Protein Hydrolysates
In the Federal Register of January 22, 1991 (56 FR 2149), FDA
published an advance notice of proposed rulemaking (ANPRM) announcing
the filing of petitions that requested, among other things, the
establishment of new standards of identity for ``lowfat ice cream'' and
``nonfat ice cream'' and a change in the name of the standardized food
known as ``ice milk'' to ``reduced fat ice cream.'' Interested persons
were given until March 25, 1991, to comment.
One comment received in response to the ANPRM requested that FDA
amend the ice cream standard in Sec. 135.110 to provide for the use of
safe and suitable milk-derived protein ingredients other than
caseinates, provided that the milk solids content minimums required by
the standards are otherwise met (58 FR 520 at 525). The comment stated
that these ``other milk protein ingredients'' include milk protein
hydrolysates (enzyme-modified milk protein) and milk protein isolates
(caseinates and whey protein co-isolates). The comment maintained that
the use of milk proteins other than caseinates contributes to aeration
of frozen lowfat dairy desserts, thereby improving the body and texture
of these products, and that their use will not reduce the nutritional
value of standardized dairy products. It further stated that these
ingredients are safe and suitable for use in other nonstandardized
foods such as frozen yogurt, coffee whiteners, infant formulas,
fortified cereals, and medical foods.
In the proposal, FDA acknowledged that milk protein hydrolysates
are generally recognized as safe (GRAS) and are now used in many foods
(58 FR 520 at 525). The agency specifically invited comments on the
nature of, and the need for, milk protein hydrolysates in ice cream; on
the proposed levels of use for these ingredients; on their suitability
to perform technical functions in the food; and on any possible adverse
effects from their use. The agency stated that it would consider
providing for the use of these ingredients in any final regulation that
resulted from the proposal if the comments that it received on this
issue adequately supported the need for these ingredients in ice cream.
FDA already provides for the optional use of modified whey
products, which would include whey protein isolates, as well as for the
optional use of caseinates, in ice cream within the limitations set
forth in the ice cream standard. The ice cream standard in
Sec. 135.110(b) permits the use of modified whey products that are GRAS
for use in the food, provided that any whey and modified whey products
used contribute, singly or in combination, not more than 25 percent by
weight of the total nonfat milk solids content of the finished food.
Further, the ice cream standard permits the optional use of caseinates
in ice cream mix containing not less than 20 percent total milk solids.
5. One comment suggested that FDA permit the optional use of safe
and suitable milk-derived proteins, such as milk protein hydrolysates,
in ice cream at levels of 1 to 3 percent. Concerning the nature of milk
protein hydrolysates, the comment stated that these products are
produced by light enzymatic hydrolysis of casein; that they are high in
protein (85 percent); and that they have the same nutritional value as
the caseinates from which they are derived. The comment stated that
milk protein hydrolysates may be used in ice cream to stabilize the
food, i.e., to improve its body and texture; to enhance aeration; and
to impart resistance to heat shock. The comment also noted that, in
addition to the nonstandardized foods listed previously, milk protein
hydrolysates have been used in nonstandardized frozen desserts and
confectionery nougats. The comment stated that, while these milk
protein hydrolysates provide a similar degree of stabilization as
nondairy optional ingredients such as vegetable gums, they are
nutritionally superior to those ingredients.
FDA acknowledges that hydrolyzed milk proteins, like vegetable
gums, may be used to stabilize foams in foods. In addition, FDA
recognizes that they also may be used to enhance aeration and to
improve body and texture of products such as nougats and frappes. These
ingredients are also generally recognized as safe for use in infant
formulas, as well as in other food products. Thus, the agency finds
that it is appropriate to provide for their use as stabilizers in ice
cream. Therefore, the agency is revising the ice cream standard to
permit the optional use of hydrolyzed milk proteins, in addition to
optional caseinates, in ice cream when the milk solids content minimum
provided for in the standard is met.
Accordingly, the agency is amending Sec. 135.110 by revising
paragraph (a) and adding new paragraph (d) to provide for the optional
use of hydrolyzed milk proteins as stabilizers. Based upon the
information submitted with the comment on this matter, FDA is providing
in Sec. 135.110(d) that hydrolyzed milk proteins may be used at a level
not to exceed 3 percent by weight of ice cream mix containing not less
that 20 percent of total milk solids (see Sec. 135.110(a)(2)). Any whey
or modified whey products contained in the milk protein hydrolysates
must fall within the limitations in Sec. 135.110(b) on the total level
of whey products in ice cream; that is, singly or in combination, they
must not contribute more than 25 percent by weight of the total nonfat
milk solids content of the finished food.
Because the comment did not submit any information concerning the
use of hydrolyzed milk proteins in goat's milk ice cream, the agency is
not providing for their use in goat's milk ice cream in Sec. 135.115.
FDA advises that all protein hydrolysates used in foods must be
declared in the list of ingredients by a common or usual name that is
specific to the ingredient and that includes the identity of the food
source from which the protein was derived. Thus, when hydrolyzed milk
proteins are used in ice cream, the declaration of these ingredients on
the food label shall comply with the requirements in 21 CFR 102.22.
``Hydrolyzed casein'' and ``hydrolyzed whey protein'' would be
acceptable common or usual names for products derived from casein or
whey protein, whereas ``hydrolyzed milk protein'' would not be an
acceptable name.
B. Lactose Reduction in or Removal from Dairy Ingredients by Alternate
Technologies
One comment received in response to the ANPRM requested that FDA
revise Sec. 135.110(b) to replace the phrase ``skim milk that has been
concentrated and from which part of the lactose has been removed by
crystallization'' with ``skim milk [that] may be concentrated and from
which part of the lactose has been removed by crystallization,
ultrafiltration, or other approved technologies.'' In the proposal, FDA
tentatively found that it would be appropriate to amend the ice cream
standard to permit the addition of concentrated skim milk from which
part of the lactose has been removed by ultrafiltration. The agency
stated that it also appeared to be appropriate to provide for the
removal of part or all of the lactose by any safe and suitable
procedure in order to give manufacturers the opportunity to use state-
of-the-art processing technologies as long as the nutritional quality
of the resulting food is not detrimentally affected. It stated that
this approach will minimize the need to revise the standard should
other acceptable procedures be developed for lactose reduction or
removal at a later date. Accordingly, FDA proposed to amend
Sec. 135.110(b) in the ice cream standard to provide for the addition
to the food of skim milk that may be concentrated and from which part
or all of the lactose has been removed by a safe and suitable
procedure.
6. All of the comments on this provision supported it. One comment,
however, requested that ultrafiltration for lactose reduction be
extended to other suitable dairy ingredients because skim milk is not
the only milk-based dairy ingredient that can be processed by
ultrafiltration to remove lactose.
FDA recognizes that ultrafiltration can be used to remove part or
all of the lactose from milk-based dairy ingredients other than skim
milk. However, in the proposal, the agency did not foreshadow any
changes in the ice cream standard to provide for the use of
ultrafiltration to remove part or all of the lactose from any optional
dairy ingredient listed in Sec. 135.110(b) other than ``skim milk, that
may be concentrated, and from which part or all of the lactose has been
removed by a safe and suitable procedure.'' Therefore, the modification
in Sec. 135.110 requested by this comment is outside the scope of this
rulemaking. Persons interested in providing, in ice cream, for the use
of additional ingredients that are processed by ultrafiltration to
remove lactose may petition the agency to amend the standard.
Therefore, FDA is amending Sec. 135.110(b) of the ice cream
standard, as proposed, to allow for the use of skim milk that may be
concentrated, and from which part or all of the lactose has been
removed by a safe and suitable procedure, in the food.
C. Additional Comments
7. One comment suggested an alternative scheme of nomenclature for
ice cream products based on percentage milkfat. The comment suggested
that products bearing the term ``nonfat'' would contain 0 percent
milkfat; products bearing the term ``lowfat,'' greater than 0 but less
than 3 percent milkfat; products bearing the term ``reduced fat,'' 3 to
7 percent milkfat; and products bearing the name ``ice cream,'' greater
than 7 percent milkfat.
This request is outside the scope of the proposal. In the Federal
Register of January 6, 1993, FDA published a number of final rules
establishing food labeling regulations that, in part, were intended to
eliminate consumer confusion by establishing definitions for nutrient
content claims. In one of these final rules (58 FR 2302), FDA
established uniform, consistent definitions for a number of nutrient
content claims, including terms for specific fat content claims, and
prescribed the specific labeling that must accompany these claims.
Terms for specific fat content claims such as ``nonfat,'' ``lowfat,''
and ``reduced fat'' are defined in Sec. 101.62. In defining terms for
specific nutrient content claims, the agency carefully considered each
claim to ensure that it would be meaningful to consumers.
In another final rule (58 FR 2431), FDA amended its general
provisions for food standards to provide a general definition and
standard of identity for foods named by the use of a nutrient content
claim defined in part 101 (such as ``fat free'') in conjunction with a
traditional standardized name (e.g., ``ice cream''). In accordance with
Sec. 130.10, specific fat content claims defined in Sec. 101.62 may be
used in conjunction with the standardized term ``ice cream'' for foods
that resemble and substitute for ice cream but that contain less fat
(both milkfat and total fat) than traditional ice cream.
Thus, the agency has addressed in separate rulemakings (58 FR 2302
and 58 FR 2431) the types of nutrient content claims that can be used
to indicate the amount of fat present in foods, including ice cream
products. Further, in this final rule, the agency is removing the
standard of identity for ice milk, so that a reduced fat ice cream
product that complies with the existing standard of identity for ice
milk no longer needs to be labeled ``ice milk'' and may now be labeled
as ``reduced fat ice cream.''
FDA notes that the percentage milkfat basis for the labeling of ice
cream products suggested by the comment is inconsistent with the
definitions that the agency has established in its food labeling
regulations. Further, the agency believes that the adoption of the
suggested alternative scheme of nomenclature for ice cream products
could result in consumer confusion about the nature of the food.
Therefore, FDA concludes that an alternative scheme of nomenclature for
ice cream products, as suggested by the comment, would neither promote
uniformity and consistency in the food labeling nor minimize confusion
among consumers. Thus, the agency is not making the requested change in
the regulations set out below.
8. One comment stated that under existing FDA regulations, frozen
dairy products containing 7 to 10 percent milkfat have no standard of
identity.
This comment is no longer correct now that the regulation (58 FR
2431) amending the general provisions for food standards to prescribe a
general definition and standard of identity for foods named by the use
of a nutrient content claim in conjunction with a traditional
standardized name has been finalized. Under Sec. 130.10, FDA-defined
nutrient content claims for fat content, such as ``reduced fat,''
``lowfat,'' and ``nonfat,'' can be used in conjunction with the name of
a traditional standardized food such as ``ice cream'' for foods that
resemble and substitute for ice cream but that contain less milkfat
than traditional ice cream. Therefore, manufacturers may be able to use
an appropriate term such as ``reduced fat'' in conjunction with the
standardized name ``ice cream'' to name ice cream products containing
greater than 7 percent but less than 10 percent milkfat, provided that
the use of the term complies with Sec. 130.10 and is not false or
misleading to consumers. For example, if the manufacturer's regular
vanilla ice cream contains 12 percent milkfat, and the manufacturer
reduces the fat level of the product by 25 percent, the new version of
the product would contain 9 percent milkfat, which falls in the range
of milkfat that the comment mentioned (i.e., greater than 7 percent but
less than 10 percent). The manufacturer would be able to label the new
version of the product with the term ``reduced fat'' because the
product would contain 25 percent less fat per serving than the
manufacturer's regular vanilla ice cream.
9. FDA received from a law firm a request for an advisory opinion
(Docket No. 93A-0493), dated December 10, 1993, as to whether a frozen
dessert product that contains less than 2 percent milkfat and more than
2 percent total fat may be labeled as ``reduced fat ice cream.'' The
law firm represents a company that desires to avoid using the name
``ice milk'' on the label of its product.
Before issuance of this final rule, ``ice milk'' was defined in
Sec. 135.120 as a frozen dessert that contained more than 2 percent
milkfat and not more than 7 percent milkfat. With the issuance of the
January 1993 final rules, however, a frozen dessert product that
contained less than 2 percent milkfat and more than 2 percent total
fat, such as that described by the law firm, could have been eligible
to be labeled as ``reduced fat ice cream'' in accordance with
Sec. 130.10(a), because it contained less than 2 percent milkfat, but
provided that: (1) Any additional fat (above the 2 percent maximum
level for milkfat) in the food was there as a component of a flavoring
constituent, e.g., fat from nut meats, butterscotch, or chocolate, and
not as a replacement of milkfat, and (2) the food was made in
compliance with the provisions of Sec. 130.10. The product described in
the request was outside the scope of the ice milk standard and would
have had to comply with the provisions of Sec. 130.10(b), (c), and (d)
with respect to nutrients, performance characteristics, permitted
ingredients, and labeling. FDA notes that replacement of the milkfat of
ice cream with fats from other sources is contrary to Sec. 130.10(d)(2)
because it would alter the dairy character of the food.
If the product described in the request complied with Sec. 130.10,
it would have been named, ``reduced fat'' or ``low fat'' ice cream. The
product would have qualified for the use of the ``reduced fat'' claim,
as defined in Sec. 101.62(b)(4), as part of its name because the total
level of fat contained in the product would have been at least 25
percent less fat than ice cream. On the other hand, the product could
have borne the ``low fat'' claim as defined in Sec. 101.62(b)(2) as
part of its name if it contained less than 3 grams of total fat per
reference amount customarily consumed.
The agency points out that now, with the removal of the ice milk
standard in this final rule, the foregoing is still the case except
that modified ice cream products that contain levels of milkfat within
the range of that previously prescribed by the standard of identity for
ice milk (i.e., more than 2 percent but not more than 7 percent) may
also be labeled as ``reduced fat ice cream,'' provided that these
products comply with the provisions of Sec. 130.10.
III. Conclusions
After review and consideration of the comments received in response
to the proposal, FDA concludes that no evidence or information has been
presented that would provide a basis for altering the agency's
tentative determination that it should remove the standards of identity
for ice milk (Sec. 135.120) and goat's milk ice milk (Sec. 135.125),
and that it should amend the standards of identity for ice cream
(Sec. 135.110) and goat's milk ice cream (Sec. 135.115) to provide for
the use in the food of safe and suitable sweeteners and of skim milk
that may be concentrated and from which part or all of the lactose has
been removed by a safe and suitable procedure.
Therefore, in this final rule, FDA is removing the standards of
identity for ice milk (Sec. 135.120) and goat's milk ice milk
(Sec. 135.125) as proposed and amending the standards of identity for
ice cream (Sec. 135.110) and goat's milk ice cream (Sec. 135.115) as
proposed with the following exceptions: (1) Ice cream sweetened with
alternative sweeteners, or goat's milk ice cream sweetened with
alternative sweeteners, needs to bear labeling in accordance with the
requirements of part 105 only if the food purports to be or is
represented for special dietary use; (2) the name of the alternative
sweetener need only be included as part of the name of the food on the
principal display panel of the label for a period of 3 years; and (3)
hydrolyzed milk proteins may be used as optional stabilizers in ice
cream at a level not to exceed 3 percent by weight in ice cream mix
containing not less that 20 percent total milk solids, provided that
any whey and modified whey products used contribute, singly or in
combination, not more than 25 percent by weight of the total nonfat
milk solids content of the finished food.
In addition, FDA has made other minor editorial revisions in the
text of the final rule for internal consistency. The agency deleted the
language ``or may not'' from the last sentence in Sec. 135.110(a)(1) of
the ice cream standard and redesignated Sec. 135.110(d) through (f) of
the ice cream standard as Sec. 135.110(e) through (g).
Because this rulemaking involves the removal and amendment of
standards for dairy products, it is subject to the formal rulemaking
procedures of section 701(e) of the act (21 U.S.C. 371(e)). Section
701(e) of the act, unlike the informal rulemaking procedures of section
701(a) of the act, requires that the agency provide an opportunity for
objections to the final rule. If any objection raises issues of
material fact, the agency is to hold a formal evidentiary hearing on
those issues.
IV. Analysis of Impacts
FDA has examined the impact of this final rule to amend the
standards of identity for ice cream and goat's milk ice cream and to
repeal the standards of identity for ice milk and goat's milk ice cream
in 21 CFR part 135 as required by Executive Order 12866 and the
Regulatory Flexibility Act. Executive Order 12866 directs agencies to
assess all costs and benefits of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety effects; distributive impacts and equity). The
Regulatory Flexibility Act (Pub. L. 96-354) requires that the agency
analyze options for regulatory relief for small businesses. FDA finds
that this final rule is not a significant regulatory action as defined
by Executive Order 12866. In compliance with the Regulatory Flexibility
Act, the agency certifies that this final rule will not have a
significant impact on a substantial number of small businesses.
V. Environmental Impact
FDA has previously considered the environmental effects of this
rule as announced in the proposed rule. No new information or comments
have been received that would affect the agency's previous
determination that there is no significant impact on the human
environment and that an environmental impact statement is not required.
VI. Objections
Any person who will be adversely affected by this regulation may at
any time on or before October 14, 1994, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection for which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish
notice of the objections that the agency has received or lack thereof
in the Federal Register.
List of Subjects in 21 CFR Part 135
Food grades and standards, Food labeling, Frozen foods, Ice cream.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
135 is amended as follows:
PART 135--FROZEN DESSERTS
1. The authority citation for 21 CFR part 135 is revised to read as
follows:
Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,
379e).
2. Section 135.110 is amended by revising paragraphs (a)(1) and
(b), by redesignating paragraphs (d) through (f) as paragraphs (e)
through (g), and by adding new paragraphs (d) and (f)(7) to read as
follows:
Sec. 135.110 Ice cream and frozen custard.
(a) Description. (1) Ice cream is a food produced by freezing,
while stirring, a pasteurized mix consisting of one or more of the
optional dairy ingredients specified in paragraph (b) of this section,
and may contain one or more of the optional caseinates specified in
paragraph (c) of this section subject to the conditions hereinafter set
forth, one or more of the optional hydrolyzed milk proteins as provided
for in paragraph (d) of this section subject to the conditions
hereinafter set forth, and other safe and suitable nonmilk-derived
ingredients; and excluding other food fats, except such as are natural
components of flavoring ingredients used or are added in incidental
amounts to accomplish specific functions. Ice cream is sweetened with
safe and suitable sweeteners and may be characterized by the addition
of flavoring ingredients.
* * * * *
(b) Optional dairy ingredients. The optional dairy ingredients
referred to in paragraph (a) of this section are: Cream; dried cream;
plastic cream (sometimes known as concentrated milkfat); butter; butter
oil; milk; concentrated milk; evaporated milk; sweetened condensed
milk; superheated condensed milk; dried milk; skim milk; concentrated
skim milk; evaporated skim milk; condensed skim milk; superheated
condensed skim milk; sweetened condensed skim milk; sweetened condensed
part-skim milk; nonfat dry milk; sweet cream buttermilk; condensed
sweet cream buttermilk; dried sweet cream buttermilk; skim milk, that
may be concentrated, and from which part or all of the lactose has been
removed by a safe and suitable procedure; skim milk in concentrated or
dried form that has been modified by treating the concentrated skim
milk with calcium hydroxide and disodium phosphate; and whey and those
modified whey products (e.g., reduced lactose whey, reduced minerals
whey, and whey protein concentrate) that have been determined by FDA to
be generally recognized as safe (GRAS) for use in this type of food.
Water may be added, or water may be evaporated from the mix. The sweet
cream buttermilk and the concentrated sweet cream buttermilk or dried
sweet cream buttermilk, when adjusted with water to a total solids
content of 8.5 percent, has a titratable acidity of not more than 0.17
percent, calculated as lactic acid. The term ``milk'' as used in this
section means cow's milk. Any whey and modified whey products used
contribute, singly or in combination, not more than 25 percent by
weight of the total nonfat milk solids content of the finished food.
The modified skim milk, when adjusted with water to a total solids
content of 9 percent, is substantially free of lactic acid as
determined by titration with 0.1N NaOH, and it has a Ph value in the
range of 8.0 to 8.3.
* * * * *
(d) Optional hydrolyzed milk proteins. One or more of the optional
hydrolyzed milk proteins referred to in paragraph (a) of this section
may be added as stabilizers at a level not to exceed 3 percent by
weight of ice cream mix containing not less that 20 percent total milk
solids, provided that any whey and modified whey products used
contribute, singly or in combination, not more than 25 percent by
weight of the total nonfat milk solids content of the finished food.
Further, when hydrolyzed milk proteins are used in the food, the
declaration of these ingredients on the food label shall comply with
the requirements of Sec. 102.22 of this chapter.
* * * * *
(f) * * *
(7) Until September 14, 1998, when safe and suitable sweeteners
other than nutritive carbohydrate sweeteners are used in the food,
their presence shall be declared by their common or usual name on the
principal display panel of the label as part of the statement of
identity in letters that shall be no less than one-half the size of the
type used in the term ``ice cream'' but in any case no smaller than
one-sixteenth of an inch. If the food purports to be or is represented
for special dietary use, it shall bear labeling in accordance with the
requirements of part 105 of this chapter.
* * * * *
3. Section 135.115 is amended by revising paragraph (a), by
redesignating the text of paragraph (c) as paragraph (c)(1), and by
adding new paragraph (c)(2) to read as follows:
Sec. 135.115 Goat's milk ice cream.
(a) Description. Goat's milk ice cream is the food prepared in the
same manner prescribed in Sec. 135.110 for ice cream, and complies with
all the provisions of Sec. 135.110, except that the only optional dairy
ingredients that may be used are those in paragraph (b) of this
section; caseinates and hydrolyzed milk proteins may not be used; and
paragraphs (f)(1) and (g) of Sec. 135.110 shall not apply.
* * * * *
(c) * * *
(2) Until September 14, 1998, when safe and suitable sweeteners
other than nutritive carbohydrate sweeteners are used in the food,
their presence shall be declared by their common or usual name on the
principal display panel of the label as part of the statement of
identity in letters that shall be no less than one-half the size of the
type used in the term ``goat's milk ice cream'' but in any case no
smaller than one-sixteenth of an inch. If the food purports to be or is
represented for special dietary use, it shall bear labeling in
accordance with the requirements of part 105 of this chapter.
* * * * *
Sec. 135.120 [Removed]
4. Section 135.120 Ice milk is removed from subpart B.
Sec. 135.125 [Removed]
5. Section 135.125 Goat's milk ice milk is removed from subpart B.
Dated: September 7, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-22646 Filed 9-13-94; 8:45 am]
BILLING CODE 4160-01-F