[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Pages 32303-32307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket Nos. FDA-2014-C-1616 and FDA-2015-C-0245]


Listing of Color Additives Exempt From Certification; Mica-Based 
Pearlescent Pigments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (``FDA'' or ``we'') is 
amending the color additive regulations to provide for the safe use of 
mica-based pearlescent pigments prepared from titanium dioxide and mica 
as color additives in cordials, liqueurs, flavored alcoholic malt 
beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and 
mixes, and in egg decorating kits for coloring shell eggs. This action 
is in response to two color additive petitions (CAPs) submitted 
separately by EMD Millipore Corp. and by Signature Brands, LLC.

DATES: This rule is effective July 9, 2015. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing by July 8, 
2015.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing identified by Docket No. FDA-2014-C-1616 (Mica-
based pearlescent pigments in cordials, liqueurs, flavored alcoholic 
malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers 
and mixes) or Docket No. FDA-2015-C-0245 (Mica-based pearlescent 
pigments in egg decorating kits), by any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug

[[Page 32304]]

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2014-C-1616 (Mica-based pearlescent pigments in 
cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, 
cocktails, non-alcoholic cocktail mixers and mixes) or Docket No. FDA-
2015-C-0245 (Mica-based pearlescent pigments in egg decorating kits) 
for this rulemaking. All objections received will be posted without 
change to http://www.regulations.gov, including any personal 
information provided. For detailed instructions on submitting 
objections, see the ``Objections'' heading of the SUPPLEMENTARY 
INFORMATION section.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket numbers, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.

SUPPLEMENTARY INFORMATION: 

I. Background

    In notices published in the Federal Register on October 21, 2014, 
and February 5, 2015 (79 FR 62932 and 80 FR 6468, respectively), we 
announced that we filed CAPs (4C0299 and 5C0301, respectively) to amend 
the color additive regulations in Sec.  73.350 Mica-based pearlescent 
pigments (21 CFR 73.350).
    CAP 4C0299 was submitted by EMD Millipore Corp. (EMD), c/o Hyman, 
Phelps & McNamara, P.C., 700 13th St. NW., Suite 1200, Washington, DC 
20005. CAP 4C0299 proposed to amend the color additive regulations in 
Sec.  73.350 to expand the safe use of mica-based pearlescent pigments 
prepared from titanium dioxide and mica as a color additive in 
cordials, liqueurs, cocktails, and certain other alcoholic beverages, 
and non-alcoholic cocktail mixers and mixes. The maximum use level of 
the pigments proposed by the petitioner is 0.07 percent by weight in 
the beverages, mixers, and mixes, consistent with approval in Sec.  
73.350(c)(1)(ii) for the use of mica-based pearlescent pigments in 
distilled spirits containing not less than 18 percent and not more than 
23 percent alcohol by volume, but not including distilled spirits 
mixtures containing more than 5 percent wine on a proof gallon basis. 
In correspondence with FDA, EMD subsequently refined the petitioned use 
of mica-based pearlescent pigments to cordials, liqueurs, flavored 
alcoholic malt beverages, wine coolers, cocktails, and non-alcoholic 
cocktail mixers and mixes.
    CAP 5C0301 was submitted by Signature Brands, LLC, c/o Keller and 
Heckman, LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001. CAP 
5C0301 proposed to amend Sec.  73.350 to provide for the safe use of 
mica-based pearlescent pigments prepared from titanium dioxide and mica 
in egg decorating kits for coloring boiled shell eggs, in amounts 
consistent with good manufacturing practice (GMP).
    Mica-based pearlescent pigments prepared from titanium dioxide and 
mica are currently approved under Sec.  73.350(c)(1)(i) for use as a 
color additive in amounts up to 1.25 percent by weight in cereals, 
confections and frostings, gelatin deserts, hard and soft candies 
(including lozenges), nutritional supplement tablets and gelatin 
capsules, and chewing gum. Mica-based pearlescent pigments prepared 
from titanium dioxide and mica are also currently approved under Sec.  
73.350(c)(1)(ii) in amounts up to 0.07 percent, by weight, in distilled 
spirits containing not less than 18 percent and not more than 23 
percent alcohol by volume, but not including distilled spirits mixtures 
containing more than 5 percent wine on a proof gallon basis. Mica-based 
pearlescent pigments prepared from titanium dioxide on mica, iron oxide 
on mica, and titanium dioxide and iron oxide on mica are approved for 
specified uses as a color additive in ingested drugs under Sec.  
73.1350 (21 CFR 73.1350). Mica-based pearlescent pigments formed by 
depositing titanium or iron salts from a basic solution onto mica, 
followed by calcination to produce titanium dioxide or iron oxides on 
mica, are approved for specified uses in contact lenses under Sec.  
73.3128 (21 CFR 73.3128). The color additive that is the subject of the 
two color additive petitions at issue, mica-based pearlescent pigments 
prepared from titanium dioxide and mica, will be referred hereinafter 
in this final rule as mica-based pearlescent pigments.

II. Safety Evaluation

A. Determination of Safety

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be 
listed for a particular use unless the data and information available 
to FDA establish that the color additive is safe for that use. FDA's 
color additive regulations in 21 CFR 70.3(i) define ``safe'' to mean 
that there is convincing evidence that establishes with reasonable 
certainty that no harm will result from the intended use of the color 
additive. To establish with reasonable certainty that a color additive 
intended for use in food is not harmful under its intended conditions 
of use, we consider the projected human dietary exposure to the 
additive, the additive's toxicological data, and other relevant 
information (such as published literature) available to us. We compare 
an individual's estimated daily intake (EDI) of the additive from all 
food sources to an acceptable daily intake (ADI) established by 
toxicological data. The EDI is determined by projections based on the 
amount of the additive proposed for use in particular foods and on data 
regarding the amount consumed from all food sources of the additive. We 
typically use the EDI for the 90th percentile consumer of a color 
additive as a measure of high chronic dietary exposure.

B. Petitioned Uses of the Color Additive

    In CAP 4C0299, EMD proposed to amend the color additive regulations 
in Sec.  73.350 to provide for the safe use of mica-based pearlescent 
pigments as a color additive in amounts up to 0.07 percent, by weight, 
in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, 
cocktails, and non-alcoholic cocktail mixes and mixers. According to 
the standards of identity for distilled spirits regulations issued by 
the Alcohol and Tobacco Tax and Trade Bureau (TTB), which regulates the 
labeling of certain alcoholic beverages, cordials and liqueurs are a 
class of distilled spirits obtained by mixing or redistilling distilled 
spirits with or over fruits, flowers, plants, or pure juices therefrom, 
or other natural flavoring materials, or with extracts derived from 
infusions, percolation, or maceration of such materials, and containing 
sugar, dextrose, or levulose, or a combination thereof, in an amount 
not less than 2\1/2\ percent by weight of the finished product (27 CFR 
5.22(h)). Neither FDA nor TTB has a regulatory definition for 
``cocktail.'' The petition defines cocktails as ``products that are 
sold as mixtures of distilled spirits and non-alcoholic ingredients.'' 
Subsequent communication with the petitioner clarified that the 
following are descriptions of the types of cocktail products included 
within the scope of the petition: (1) Cocktails containing

[[Page 32305]]

one or more alcoholic beverages and one or more non-alcoholic mixers 
(e.g., margarita, gin and tonic, cosmopolitan, fuzzy navel, Bloody 
Mary, caipirinha, Irish coffee, Long Island iced tea, daiquiri, 
hurricane); (2) cocktails containing one or more alcoholic beverages 
without non-alcoholic mixers (e.g., vodka martini, stinger, black 
Russian, Manhattan); (3) cocktails containing beer (e.g., caipbeerinha, 
boilermaker, beer Bloody Mary); (4) cocktails containing wine (e.g., 
mimosa, Kir Royale, wine cooler, wine spritzer); and (5) non-alcoholic 
mixes and mixers for use in cocktails (e.g., margarita mix, daiquiri 
mix, Bloody Mary mix). We note that mica-based pearlescent pigments are 
intended to be used in both liquid and powdered forms of non-alcoholic 
cocktail mixes and mixers, at a maximum use level of 0.07 percent by 
weight of the mix or mixer (Ref. 1). Furthermore, only non-alcoholic 
mixes and mixers that are marketed specifically for use in cocktails, 
such as margarita mix and Bloody Mary mix, are included within the 
scope of this petition (Ref. 1). Beverages that are typically consumed 
without added alcohol (e.g., fruit juices, carbonated water, soft 
drinks) are outside the scope of this petition. The petition also 
proposed to amend Sec.  73.350 to provide for the safe use of mica-
based pearlescent pigments in flavored alcoholic malt beverages and 
wine coolers. Like ``cocktail,'' the term ``wine cooler'' does not have 
a regulatory definition. According to TTB, products traditionally known 
as wine coolers have generally been replaced in recent years by 
flavored alcoholic malt beverages, which are manufactured with a malt 
base rather than with wine (Ref. 1). Flavored alcoholic malt beverages 
are sold under many proprietary names and include alcoholic lemonades, 
alcoholic colas, and other flavored alcoholic beverages (see 70 FR 194 
at 195 (January 3, 2005) (TTB final rule pertaining to ``Flavored Malt 
Beverage and Related Regulatory Amendments'')). Products marketed as 
wine coolers and flavored alcoholic malt beverages are included in the 
scope of the petition to amend the color additive regulations in Sec.  
73.350. Traditional malt beverages, such as beer, ale, and malt liquor, 
differ substantially from flavored alcoholic malt beverages (see 70 FR 
194) and are not included within the scope of the petition. Wine, which 
has a standard of identity defined under TTB's regulations at 27 CFR 
part 4, subpart C, is also outside the scope of the petition. 
Furthermore, the petitioner clarified that the scope of the petition 
does not include sangria, which is typically a mixture of wine, fruit, 
and other ingredients.
    In CAP 5C0301, Signature Brands, LLC proposed to amend the color 
additive regulations in Sec.  73.350 to provide for the safe use of 
mica-based pearlescent pigments as a color additive in egg decorating 
kits to color the shells of boiled eggs in amounts consistent with GMP. 
The petitioner proposed to use mica-based pearlescent pigments in a 
packet of glaze that is part of egg decorating kits sold for in-home 
use. According to the kit instructions, the glaze containing the mica-
based pearlescent pigments is intended to be rubbed on the shells of 
colored boiled eggs to impart a metallic sheen.

C. Safety of the Petitioned Uses of the Color Additive

    During our safety review of the uses of mica-based pearlescent 
pigments proposed in CAPs 4C0299 and 5C0301, we considered the exposure 
to the color additive from its petitioned uses and from the currently 
permitted uses in food and ingested drugs under Sec. Sec.  73.350 and 
73.1350, respectively. In estimating the cumulative estimated dietary 
intake (CEDI) of these pigments, we determined that the exposure to 
mica-based pearlescent pigments from the use in contact lenses (Sec.  
73.3128) is negligible and, therefore, need not be included in our 
exposure estimate. Furthermore, we concluded that the exposure to the 
additive from the petitioned use in coloring the shells of boiled eggs 
is also negligible. In CAP 5C0301, the petitioner noted that, because 
eggshells are not consumed, exposure to mica-based pearlescent pigments 
would be limited to the amount of additive that migrates through the 
shell and the inner membrane that separates the shell from the edible 
egg. The petitioner asserted that, given the pigments' relatively large 
particle size and insolubility in food, the amount of mica-based 
pearlescent pigments that could actually be found in the edible portion 
of the egg is insignificant. The petitioner provided a conservative 
estimate for potential exposure to the additive from the petitioned use 
based on a worst-case scenario that presumed the theoretical maximum 
solubility of mica-based pearlescent pigments is equivalent to that of 
mica (80 milligrams/kilograms in 10 percent acetic acid). Exposure to 
mica-based pearlescent pigments from decorated eggshells is likely 
further reduced by the typically limited seasonal availability of the 
egg decorating kits. We agree with the rationale proposed in CAP 5C0301 
that the exposure to the additive from the petitioned use is 
negligible, and that the petitioned use would not result in a 
significant contribution to the CEDI for mica-based pearlescent 
pigments (Ref. 2).
    We estimate the eaters-only exposure to mica-based pearlescent 
pigments from the proposed uses in cordials, liqueurs, flavored 
alcoholic malt beverages, wine coolers, cocktails, and non-alcoholic 
cocktail mixers and mixes for the U.S. population to be 0.15 grams/
person/day (g/p/d) at the mean and 0.34 g/p/d at the 90th percentile 
(Ref. 1). (An eaters-only exposure is the total of the amount of food 
consumed per day averaged over the number of days in the survey period 
by individuals consuming the food at least once during the survey 
period.) In a previous amendment to Sec.  73.350 (78 FR 35115 at 35115 
and 35116 (June 12, 2013)), we estimated a CEDI for the use of mica-
based pearlescent pigments in food (Sec.  73.350) and ingested drugs 
(Sec.  73.1350) using food consumption data from the 2003 to 2008 
National Health and Nutrition Examination Survey (NHANES). In our 
current safety assessment, we updated the previous exposure to mica-
based pearlescent pigments from all approved uses in foods using NHANES 
food consumption data from 2007 to 2010. In estimating the exposure to 
mica-based pearlescent pigments from the use in ingested drugs, we 
relied on the estimates used in a previous safety evaluation (Ref. 1). 
The updated eaters-only CEDI of mica-based pearlescent pigments, 
including the petitioned use in cordials, liqueurs, flavored alcoholic 
malt beverages, wine coolers, cocktails, and non-alcoholic cocktail 
mixers and mixes, and the currently approved uses in food and ingested 
drugs, is 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile 
for the U.S. population (Ref. 1). The updated CEDIs for mica-based 
pearlescent pigments are not significantly different from the previous 
CEDIs (78 FR 35115 at 35116). This is not unexpected, as both the 
previous and updated exposure estimates were based on a similar set of 
NHANES food codes that included cordials, liqueurs, and cocktails (Ref. 
1). In addition, the percent of the population consuming alcoholic 
beverages from the petitioned use is significantly lower compared to 
the proportion of the population that consumes foods and ingested drugs 
containing mica-based pearlescent pigments, thereby resulting in a 
smaller contribution to the CEDI (Ref. 1).
    To support the safety of the proposed uses of mica-based 
pearlescent pigments in food, the petitioners of CAPs 4C0299 and 5C0301 
referenced the safety

[[Page 32306]]

determination made by FDA for previously filed petitions (70 FR 42271 
(July 22, 2005); 71 FR 31927 (June 2, 2006); and 78 FR 35115). In a 
prior safety evaluation, we concluded that the bioavailability of 
ingested mica-based pearlescent pigments and/or their individual 
components is expected to be low based on the chemical nature of these 
inorganic pigments and their individual components and the low 
solubility of mica-based pearlescent pigments in media relevant to 
human health (e.g., digestive fluids in the gastrointestinal tract) (70 
FR 42271 at 42272). We are not aware of any new studies on the 
bioavailability of mica-based pearlescent pigments published since our 
previous evaluation (70 FR 42271). As part of our current safety 
evaluation, we also reviewed several recent studies on titanium 
dioxide, which is a component of mica-based pearlescent pigments, to 
further clarify the extent of the color additive's bioavailability. We 
determined that the new information on titanium dioxide supports our 
previous conclusion that mica-based pearlescent pigments are not 
bioavailable to any significant extent upon ingestion (Ref. 3).
    In our previous safety evaluation, which the petitioners 
referenced, we established an ADI for mica-based pearlescent pigments 
to be 1.8 g/p/d based on a 2-year rat carcinogenicity bioassay (71 FR 
31927 at 31928). Since the updated CEDI (0.50 g/p/d at the 90th 
percentile) for mica-based pearlescent pigments for the U.S. population 
is less than the ADI, we conclude that the proposed expanded use of 
mica-based pearlescent pigments as a color additive at levels of up to 
0.07 percent by weight in cordials, liqueurs, flavored alcoholic malt 
beverages, wine coolers, cocktails, and non-alcoholic cocktail mixers 
and mixes is safe (Ref. 3). We also conclude that the proposed expanded 
use of mica-based pearlescent pigments in egg decorating kits to color 
the shells of eggs at levels consistent with GMP is safe, since the 
exposure to mica-based pearlescent pigments contributed by this use is 
negligible (Ref. 3).

III. Conclusion

    Based on the data and information in the petitions and other 
relevant material, FDA concludes that the petitioned use of mica-based 
pearlescent pigments prepared from titanium dioxide and mica as a color 
additive at levels of up to 0.07 percent by weight in cordials, 
liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, 
and non-alcoholic cocktail mixers and mixes is safe. We also conclude 
that the petitioned use of mica-based pearlescent pigments prepared 
from titanium dioxide and mica as a color additive in egg decorating 
kits used to color the shells of eggs in amounts consistent with GMP is 
safe. We further conclude that the additive will achieve its intended 
technical effect and is suitable for the petitioned uses. Therefore, we 
are amending the color additive regulations in part 73 (21 CFR part 73) 
as set forth in this document. In addition, based upon the factors 
listed in 21 CFR 71.20(b), we conclude that certification of titanium 
dioxide-coated mica-based pearlescent pigments is not necessary for the 
protection of the public health.

IV. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petitions and 
the documents that we considered and relied upon in reaching our 
decision to approve the petitions will be made available for public 
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  
71.15, we will delete from the documents any materials that are not 
available for public disclosure.

V. Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the October 21, 2014, and February 5, 2015, notices of filing 
for CAPs 4C0299 and 5C0301 (79 FR 62932 and 80 FR 6468, respectively). 
For CAP 4C0299, we stated that we had determined, under 21 CFR 
25.32(k), that this action is of a type that does not individually or 
cumulatively have a significant effect on the human environment such 
that neither an environmental assessment nor an environmental impact 
statement is required. For CAP 5C0301, we stated that we had 
determined, under Sec.  25.32(r), that this action is of a type that 
does not individually or cumulatively have a significant effect on the 
human environment such that neither an environmental assessment nor an 
environmental impact statement is required. We have not received any 
new information or comments that would affect our previous 
determinations.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of these petitions was limited to section 721 of the 
FD&C Act. This final rule is not a statement regarding compliance with 
other sections of the FD&C Act. For example, section 301(ll) of the 
FD&C Act (21 U.S.C. 331(ll) prohibits the introduction or delivery for 
introduction into interstate commerce of any food that contains a drug 
approved under section 505 of the FD&C Act (21 U.S.C. 355), a 
biological product licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262), or a drug or biological product for which 
substantial clinical investigations have been instituted and their 
existence has been made public, unless one of the exemptions in section 
301(ll)(1) to (4) of the FD&C Act applies. In our review of these 
petitions, we did not consider whether section 301(ll) of the FD&C Act 
or any of its exemptions apply to food containing this additive. 
Accordingly, this final rule should not be construed to be a statement 
that a food containing this additive, if introduced or delivered for 
introduction into interstate commerce, would not violate section 
301(ll) of the FD&C Act. Furthermore, this language is included in all 
color additive final rules that pertain to food and therefore should 
not be construed to be a statement of the likelihood that section 
301(ll) of the FD&C Act applies.

VIII. Objections

    This rule is effective as shown in the DATES section, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    It is only necessary to send one set of documents. Identify 
documents with the docket number found in brackets in the

[[Page 32307]]

heading of this document. Any objections received in response to the 
regulation may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at http://www.regulations.gov. We will publish notice of the 
objections that we have received or lack thereof in the Federal 
Register.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. FDA Memorandum from H. Lee, Chemistry Review Group, Division of 
Petition Review, to E. Anderson, Regulatory Group II, Division of 
Petition Review, January 5, 2015.
2. FDA Memorandum from H. Lee, Chemistry Review Group, Division of 
Petition Review, to E. Anderson, Regulatory Group II, Division of 
Petition Review, March 13, 2015.
3. FDA Memorandum from S. Park, Toxicology Team, Division of 
Petition Review, to E. Anderson, Regulatory Group II, Division of 
Petition Review, March 18, 2015.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.



0
2. Section 73.350 is amended by revising paragraph (c)(1)(ii) and by 
adding paragraph (c)(1)(iii) to read as follows:


Sec.  73.350  Mica-based pearlescent pigments.

* * * * *
    (c) * * *
    (1) * * *
    (ii) In amounts up to 0.07 percent, by weight, in the following:
    (A) Distilled spirits containing not less than 18 percent and not 
more than 23 percent alcohol by volume but not including distilled 
spirits mixtures containing more than 5 percent wine on a proof gallon 
basis.
    (B) Cordials, liqueurs, flavored alcoholic malt beverages, wine 
coolers, and cocktails.
    (C) Non-alcoholic cocktail mixes and mixers, such as margarita mix, 
Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, 
and beverages that are typically consumed without added alcohol (e.g., 
fruit juices, fruit juice drinks, and soft drinks).
    (iii) In egg decorating kits used for coloring the shells of eggs 
in amounts consistent with good manufacturing practice.
* * * * *

    Dated: June 2, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2015-13834 Filed 6-5-15; 8:45 am]
 BILLING CODE 4164-01-P