[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Proposed Rules]
[Pages 8372-8417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4584]




[[Page 8371]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 70, et al.



Permanent Listing of Color Additive Lakes; Proposed Rule



  

  Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / Proposed 
Rules  
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[[Page 8372]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 70, 73, 74, 80, 81, 82, 101, 178, 201, and 701

[Docket Nos. 79N-0043 and 92N-0334]


Permanent Listing of Color Additive Lakes

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to list 
certain color additive lakes permanently as suitable and safe for use 
in food, drugs, and cosmetics. The agency is proposing to permit the 
use of more than one straight color in the preparation of a lake, to 
modify the nomenclature for lakes, and to simplify the batch 
certification procedure for lakes. As part of these actions, the agency 
is proposing to amend its regulations to require the preparation of 
lakes from certified batches of straight color; to provide simplified 
nomenclature for declaring color additives, including lakes, on 
cosmetic products; to require declaration of FD&C Yellow No. 5 and FD&C 
Yellow No. 6 on all foods and some drug products containing lakes of 
these straight colors; and to terminate the listing of certain straight 
colors as components of lakes for drug and cosmetic use and the listing 
of calcium salts as components of lakes for food use.
    This proposed rule is intended to complete the agency's disposition 
of the provisional list of color additives that was established under 
the transitional provisions of the Color Additive Amendments of 1960 
(the 1960 amendments) and to establish regulations prescribing 
conditions under which lakes may be prepared, labeled, and safely used 
in food, drugs, and cosmetics.

DATES: Written comments by June 3, 1996, except that comments regarding 
information collection should be submitted by April 3, 1996, but not 
later than May 3, 1996.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857. Comments regarding information collection to the Office of 
Information and Regulatory Affairs, OMB, New Executive Office Building, 
rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA. Process 
descriptions, identity information for anions in precipitants, and 
ingredient specifications for substrata (including rosin), and rosin 
samples to the Colors Technology Branch (HFS-126), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204.

FOR FURTHER INFORMATION CONTACT:
    Regarding proposed certification procedures, including proposed 
paperwork requirements, and for proposed product ingredient 
declarations:

Julie N. Barrows, Center for Food Safety and Applied Nutrition (HFS-
126), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-205-4662.

    Regarding other issues:

Arthur L. Lipman, Center for Food Safety and Applied Nutrition (HFS-
217), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-418-3073.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Identity, Manufacture, and Properties of Lakes
II. Regulatory History and Current Listings of Lakes
    A. Regulatory History of Lakes
    B. Current Listings of Lakes
    C. The 1965 Proposal for Permanent Listing of Lakes and the 1979 
Notice of Intent
III. Development of Proposed Actions for Lakes
    A. Terminology of Lakes
    B. Nomenclature of Lakes
    C. Issues Relating to Definition of Lakes and Termination of 
Certain Provisional Listings
IV. Safety Review and Proposed Actions for Lakes for Use in Foods
    A. Review of Components of Lakes for Use in Foods
    B. Specifications for Lakes for Use in Foods
    C. Certification Requirement
    D. Provisions of Proposed Sec. 74.50 Lakes for Use in Foods
V. Safety Review and Proposed Actions for Lakes for Use in Drugs and 
Cosmetics
    A. Review of Components of Lakes for Use in Drugs and Cosmetics
    B. Specifications for Lakes for Use in Drugs and Cosmetics
    C. Certification Requirement
    D. Provisions of Proposed Regulations
VI. Other Proposed Actions
    A. Removal of Provisional Listings
    B. Certification Procedure for Lakes
    C. Amendments to Other Regulations
VII. Summary of Information Requested
    A. In Situ Manufacturing Processes
    B. Identity and Specifications for Rosin
    C. Anions in Precipitants
VIII. Effective Date
IX. Inspection of Documents
X. Environmental Impact
XI. Paperwork Reduction Act
XII. Comments
XIII. References

I. Identity, Manufacture, and Properties of Lakes

    Color additives may be added to food, drugs, cosmetics, and certain 
medical devices for the purpose of imparting color. The three 
categories of color additives are: (1) ``Straight colors'' (color 
additives that have not been mixed or chemically reacted with any other 
substance); (2) lakes (color additives formed by chemically reacting a 
straight color with water-insoluble substances); and (3) mixtures 
(color additives formed by mixing a color additive with one or more 
other color additives or noncolored substances, without chemical 
reaction.)
    A lake is a water-insoluble pigment composed of a water-soluble 
straight color strongly adsorbed onto an insoluble substratum through 
use of a precipitant. The regulations in part 82 (21 CFR part 82), 
where lakes are provisionally listed, use the term ``basic radical'' to 
denote a precipitant. As more fully described in section III.A.6. of 
this document, the agency is proposing to replace the term ``basic 
radical'' with the more scientifically accurate term ``precipitant.'' 
The proposed terminology will be used throughout the rest of this 
document.
    The first step in manufacturing a lake is the preparation of an 
aqueous slurry of the substratum (e.g., alumina). This aqueous slurry 
is mixed with an aqueous solution of a straight color to produce a 
partially precipitated (or laked) product. The laking process is 
completed by the addition of a precipitant (e.g., aluminum chloride), 
which results in the production of the salt (e.g., aluminum salt) of 
the straight color and the adsorption of the salt onto the substratum. 
The resulting lake is washed, dried, and finely ground before 
marketing.
    The literature reports several variations of the basic laking 
process (Refs. 1 through 5). Some substrata are synthesized in situ; 
i.e., the components used to prepare the substratum, rather than the 
preformed substratum, are added during the laking procedure. For 
example, alumina slurries may be prepared by precipitation of hydrated 
alumina from an aluminum sulfate solution with a sodium carbonate or 
sodium hydroxide solution. These slurries are used directly in the 
synthesis of lakes, without isolation of the precipitated substratum.
    Some lakes are themselves prepared in situ. In this process, the 
chemical precursors for the straight color are mixed directly with the 
substratum and the precipitant during the laking procedure. The lake is 
produced as the 

[[Page 8373]]
straight color is synthesized, without isolation of the straight color 
as a discrete batch.
    The chemical association between the components of a lake may 
involve various types of interactions, including ionic bonds, hydrogen 
bonds, and van der Waals forces (Refs. 4 through 9). Lakes generally 
contain 10 to 40 percent by weight of the straight color. They also 
contain approximately 1 to 4 percent of the weight of the lake as the 
cationic precipitant. The remaining 56 to 89 percent, by weight, of 
lakes consists primarily of substrata. The color content of a lake 
depends on the desired color intensity and shade of the lake.
    Lakes offer many technical advantages over water-soluble straight 
colors. The chemical bonding of the color with substrata generally 
promotes light and heat stability. Furthermore, because lakes are not 
water-soluble, the use of lakes in aqueous foods reduces color 
migration.
    The agency's current regulations for lakes in part 82 were issued 
under section 203 of the Color Additive Amendments of 1960 (Pub. L. 86-
618), which provided for the temporary, provisional listing of 
commercially established colors. The regulations provide that before a 
lake may be used in a food, drug, or cosmetic product, each batch of 
the lake must be certified by FDA. When requesting certification of a 
batch of a lake, the requester submits a sample from the batch to the 
agency for analysis. If the agency finds that the concentrations of 
impurities in the sample are within the levels specified, and the batch 
otherwise appears to comply with the applicable regulations, the agency 
certifies the batch by issuing the requester a certificate showing the 
certification lot number assigned to that batch of lake.
    Lakes represent approximately 25 percent of the total poundage of 
color additives certified by FDA. Approximately 80 percent of the lakes 
certified are FD&C (food, drugs, and cosmetics) lakes and the remaining 
20 percent are D&C (drugs and cosmetics) lakes. (See section II.A. of 
this document for an explanation of the terms ``FD&C'' and ``D&C''.)

II. Regulatory History and Current Listings of Lakes

A. Regulatory History of Lakes

    Section 7 of the Food and Drugs Act of 1906 (Pub. L. 59-384) 
prohibited the use of poisonous or deleterious colors in confectionery 
and the coloring or staining of food to conceal damage or inferiority. 
In 1907, the agency, then part of the Department of Agriculture, issued 
Food Inspection Decision 76 (Ref. 10), which contains a list of seven 
straight colors approved for use in food. Between 1907 and 1939, the 
agency expanded the list of straight colors approved for use in food 
from 7 to 15. These colors were known as ``coal tar colors'' because 
they were synthesized mainly from substances obtained from coal tar. 
However, prior to 1939, the agency's list of acceptable colors did not 
include lakes of coal tar colors because such lakes were not used in 
food. Also, prior to 1938, the government program for batch analysis 
and certification of colors was voluntary.
    The Federal Food, Drug, and Cosmetic Act of 1938 (21 U.S.C. 301 et 
seq. (the act)) (Pub. L. 75-717) required FDA to list coal tar colors 
``harmless and suitable'' for use in foods, drugs, and cosmetics, and 
to certify all batches of listed colors, including lakes. The agency 
issued regulations under the act listing lakes for food use, as well as 
for drug and cosmetic use, and establishing conditions for 
certification of batches of lakes (4 FR 1922, May 9, 1939; 4 FR 3931, 
September 16, 1939; and 5 FR 1138, March 23, 1940). The agency issued 
the first certificate for a lake under the act on May 11, 1939 (Ref. 
11).
    The initial listing of lakes for food use under the act restricted 
their use to coloring shell eggs (egg dyeing) (5 FR 1138). In 1959, at 
the request of industry, the agency expanded the uses of lakes prepared 
from FD&C straight colors to encompass general use in foods (24 FR 
3818, May 13, 1959; and 24 FR 5302, June 30, 1959).
    The 1960 amendments amended the act by defining the term ``color 
additive'' (section 201(t) (21 U.S.C. 321(t))) for the first time and 
restricting the use of color additives in or on food, drugs, cosmetics, 
or the human body to those listed in FDA regulations. (The Medical 
Device Amendments of 1976 (Pub. L. 94-295) extended these restrictions 
to the use of color additives in certain medical devices.) As amended, 
the act provides that a food (section 402(c) (21 U.S.C. 342(c))), drug 
or device (section 501(a)(4) (21 U.S.C. 351(a)(4))), or cosmetic, other 
than a coal tar hair dye (section 601(e) (21 U.S.C. 361(e))), is 
adulterated if it is, bears, or contains an unsafe color additive. 
Section 721 (formerly section 706) of the amended act (21 U.S.C. 379e) 
provides for the listing of safe and suitable color additives for use 
in foods, drugs, cosmetics, and medical devices; it prohibits the 
listing of a color additive for a proposed use unless data establish 
that such use will be safe. Section 721 of the act also continues the 
requirement for certification of batches of color additives, with or 
without diluents, to determine whether each batch conforms to the 
purity and identity specifications in the applicable listing 
regulation. However, the amendments allow FDA to exempt color additives 
from batch certification if certification is unnecessary to protect the 
public health.
    Section 203 of the 1960 amendments also provided for the 
provisional listing of color additives that were commercially 
established when the 1960 amendments were enacted, pending completion 
of scientific investigations necessary to determine their safety under 
the new standard established by the 1960 amendments. The purpose of 
section 203 was to allow the use of such color additives on an interim 
basis, to the extent consistent with the public health. Section 203 
directed the agency to recognize as provisionally listed the following 
color additives: (1) Any color additive which, on the day preceding the 
enactment date, was listed and certifiable for any use or uses and for 
which a batch or batches had been certified for such use or uses prior 
to the enactment date; (2) any color additive which was commercially 
used or sold prior to the enactment date for any use or uses on any 
food, drug, or cosmetic, but was not required to be listed under the 
act; (3) synthetic beta carotene. The provisional listing was to apply 
only to the use or uses to which the certification applied, or for 
which the color additive had been commercially used or sold.
    Under the authority of the 1960 amendments, in the Federal Register 
of October 12, 1960 (25 FR 9759), the agency provisionally listed those 
color additives, including lakes, covered by section 203. This listing, 
originally codified as 21 CFR 8.501 and later recodified as Sec. 81.1 
(21 CFR 81.1) (42 FR 15665, March 22, 1977) included many of the coal 
tar colors (including lakes) that had been previously listed.
    In the Federal Register of December 27, 1963 (28 FR 14311), the 
agency determined that batch certification was unnecessary to ensure 
the safety of most color additives derived from plant, animal, or 
mineral sources, and designated these color additives as exempt from 
certification. However, the agency determined that batch certification 
was necessary to ensure the safety of most color additives, including 
lakes, derived principally from coal and petroleum sources, and 
designated those colors as subject to certification. Currently, the 
color additives exempt from batch certification and the permanently 
listed color additives 

[[Page 8374]]
subject to batch certification are listed in parts 73 and 74 (21 CFR 
parts 73 and 74), respectively.
    Since the establishment of the provisional list in 1960, the agency 
has gradually removed color additives from the list either by permanent 
listing or by termination of listing due to lack of interest by 
industry or due to safety concerns prompted by the agency's reviews. At 
this time, only lakes remain provisionally listed in parts 81 and 82.
    After the enactment of the act in 1938, FDA established the 
designation ``FD&C'' to identify color additives listed for use in 
foods, drugs, and cosmetics; the designation ``D&C'' to identify color 
additives listed for general use in drugs and cosmetics, but not foods; 
and the designation ``Ext. D&C'' to identify color additives listed for 
use only in externally applied drugs and cosmetics (4 FR 1922 at 1923). 
These designations are still part of the names of certified color 
additives. However, the uses of some straight colors (and consequently 
also of their lakes) were restricted when they were permanently listed, 
based on the safety reviews conducted by the agency under the 1960 
amendments. Consequently, the designations ``FD&C'' or ``D&C'' in the 
name of a certified color additive can no longer be relied upon to 
accurately describe the approved uses of the color additive.

B. Current Listings of Lakes

1. Provisional Listing and General Provisions for Lakes
    Section 81.1 identifies the provisionally listed color additives. 
The only color additives remaining on the provisional list are lakes 
(Sec. 81.1(a), (b), and (c)).
    Part 82, subpart A, prescribes the general provisions applicable to 
provisionally listed color additives. Section 82.3 contains definitions 
of terms such as ``alumina'' and ``blanc fixe.'' Section 82.5 
prescribes general specifications, including specifications for levels 
of lead, arsenic, and heavy metals other than lead and arsenic, that 
are applicable to lakes listed in the other subparts of part 82. It 
also provides a specification for the level of soluble barium 
applicable to lakes listed in subpart C or D of part 82 that contain a 
barium salt.
2. Provisional Listing of Lakes for Use in Foods, Drugs, and Cosmetics
    Part 82, subpart B, identifies the lakes that are provisionally 
listed for use in foods, drugs, and cosmetics. Section 82.50 prescribes 
the certification requirements for these lakes.
    Section 82.51 specifies that lakes for use in foods, drugs, and 
cosmetics are made by extending, on a substratum of alumina, a salt of 
one of the following certified water-soluble straight colors with the 
cation precipitant aluminum or calcium: FD&C Blue No. 1 (Sec. 82.101); 
FD&C Blue No. 2 (Sec. 82.102); FD&C Green No. 3 (Sec. 82.203); FD&C 
Yellow No. 5 (Sec. 82.705); and FD&C Yellow No. 6 (Sec. 82.706). Only 
previously certified batches of the straight color may be used. Section 
82.51 also provides specifications for soluble chlorides and sulfates 
and for inorganic matter insoluble in hydrochloric acid (HCl) and 
prescribes rules for naming the lakes that are listed for use in foods, 
drugs, and cosmetics.
3. Provisional Listing of Lakes for Use in Drugs and Cosmetics
    Part 82, subpart C, identifies the lakes that are provisionally 
listed for general use in drugs and cosmetics. Section 82.1051 
prescribes the certification requirements for these lakes, which may be 
used both in ingested and externally applied drugs and cosmetics. 
Externally applied drugs and cosmetics are those that are applied to 
the external parts of the body and not to the lips or any body surface 
covered by mucous membrane (Sec. 70.3(v) (21 CFR 70.3(v))).
    Section 82.1051 specifies that lakes for use in drugs and cosmetics 
are made by extending, on one or more listed substrata, one of the 
listed straight colors with one or more of the listed precipitants. The 
precipitant may be added either as a component of the listed straight 
color, or alone to form the salt of the listed straight color. The 
following substrata, alone or in any combination, are authorized for 
use in lakes for drug and cosmetic use: Alumina, blanc fixe, gloss 
white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum 
benzoate, and calcium carbonate. The regulation also lists the 
following cation precipitants for use in lakes for drug and cosmetic 
use: Sodium, potassium, aluminum, barium, calcium, strontium, and 
zirconium.
    The regulation provides for the use of the following straight 
colors in producing lakes for drug and cosmetic use: FD&C Blue No. 1 
(Sec. 82.101); FD&C Blue No. 2 (Sec. 82.102); FD&C Green No. 3 
(Sec. 82.203), FD&C Red No. 4 (Sec. 82.304); FD&C Yellow No. 5 
(Sec. 82.705); FD&C Yellow No. 6 (Sec. 82.706); D&C Blue No. 4 
(Sec. 82.1104), D&C Green No. 5 (Sec. 82.1205), D&C Orange No. 5
    (Sec. 82.1255), D&C Red No. 6 (Sec. 82.1306), D&C Red No. 7 
(Sec. 82.1307), D&C Red No. 21 (Sec. 82.1321), D&C Red No. 22 
(Sec. 82.1322), D&C Red No. 27 (Sec. 82.1327), D&C Red No. 28 
(Sec. 82.1328), D&C Red No. 30 (Sec. 82.1330), D&C Red No. 33 
(Sec. 82.1333), D&C Red No. 34 (Sec. 82.1334), D&C Red No. 36 
(Sec. 82.1336), D&C Violet No. 2 (Sec. 82.1602), and D&C Yellow No. 10 
(Sec. 82.1710).
    The regulations for lakes of D&C Red No. 33 (Sec. 82.1333), D&C Red 
No. 36 (Sec. 82.1336) and FD&C Yellow No. 6 (Sec. 82.706) further 
require that lakes of these straight colors for drug and cosmetic use 
be prepared from previously certified batches of the straight colors. 
Uncertified batches of the remaining straight colors may be used to 
prepare lakes for drug and cosmetic use. Section 82.1051 also provides 
specifications for ether extracts, soluble chlorides and sulfates, and 
intermediates, and prescribes rules for naming lakes that are listed 
for drug and cosmetic use.
4. Provisional Listing of Lakes for Use in Externally Applied Drugs and 
Cosmetics
    Part 82, subpart D, identifies the lakes that are provisionally 
listed for use in externally applied drugs and cosmetics. Section 
82.2050 prescribes the certification requirements for these lakes.
    Section 82.2051 specifies that lakes for use in externally applied 
drugs and cosmetics are made by extending, on one or more listed 
substrata, one or more of the listed precipitants, and the straight 
color Ext. D&C Yellow No. 7 listed in Sec. 82.2707a. The precipitant 
may be added either as a component of the listed straight color, or 
alone to form the salt of the listed straight color.
    Although Ext. D&C Yellow No. 7 is the only straight color referred 
to in subpart D, its lakes are not the only lakes limited to use in 
externally applied drugs and cosmetics. As noted above, certain 
straight colors that were provisionally listed for general drug and 
cosmetic use were restricted to use in externally applied drugs and 
cosmetics as part of their permanent listing. The agency also amended 
the provisional listings for the lakes of these straight colors to 
impose the same restrictions. The provisional listings of the following 
color additives in subparts B and C of part 82 limit the use of their 
lakes to externally applied drugs and cosmetics: FD&C Red No. 4 
(Sec. 82.304); D&C Blue No. 4 (Sec. 82.1104), D&C Green No. 6 
(Sec. 82.1206), D&C Orange No. 4 (Sec. 82.1254), D&C Orange No. 10 
(Sec. 82.1260), D&C Orange No. 11 (Sec. 82.1261), D&C Red No. 17 
(Sec. 82.1317), D&C Red No. 31 (Sec. 82.1331), D&C Yellow No. 7 
(Sec. 82.1707) and D&C Yellow No. 8 (Sec. 82.1708).
    The substrata, precipitants, and additional specifications listed 
in 

[[Page 8375]]
Sec. 82.2051 for lakes used in externally applied drugs and cosmetics 
are the same as those listed in Sec. 82.1051 for D&C lakes. Section 
82.2051 also specifies that the listed names of Ext. D&C lakes are 
derived in the same manner as for D&C lakes.
5. Permanently Listed Lakes of FD&C Red No. 40
    The color additive FD&C Red No. 40 was not included in the 
provisional list because FD&C Red No. 40 was not in use in 1960. In the 
Federal Register of April 10, 1971 (36 FR 6892), the agency published a 
final rule, in response to a color additive petition, permanently 
listing FD&C Red No. 40 for use in food and drugs. The agency later 
amended these regulations in response to another petition to provide 
for use of the lakes of FD&C Red No. 40 in food and drugs (36 FR 23553, 
December 10, 1971). Subsequently, in response to further petitions, the 
agency published final rules expanding the listing of FD&C Red No. 40 
to cosmetic uses. First, in the Federal Register of August 6, 1974 (39 
FR 28278), the agency published a final rule permanently listing FD&C 
Red No. 40 for use in dentifrices that are cosmetics. Subsequently, the 
agency amended these regulations to expand the use of FD&C Red No. 40 
and its lakes to cosmetics generally (39 FR 44198, December 23, 1974).
    The permanent listings of FD&C Red No. 40 for food, drug, and 
cosmetic use in Secs. 74.340, 74.1340, and 74.2340, respectively, 
include its lakes. However, the permanent listings of these lakes cite 
the provisional listings for lakes in part 82 for the preparation, 
specifications, and labeling requirements applicable to FD&C Red No. 40 
lakes. As a result, any agency action on the provisional listings for 
lakes will affect the permanent listings for the lakes of FD&C Red No. 
40. Therefore, this proposal includes consideration of the lakes of 
FD&C Red No. 40.

C. The 1965 Proposal for Permanent Listing of Lakes and the 1979 Notice 
of Intent

    In the Federal Register of May 11, 1965 (30 FR 6490), the agency 
proposed to list permanently certain lakes for use in foods, drugs, and 
cosmetics under conditions similar to their current provisional 
listing. However, because many straight colors were still provisionally 
listed and because of the need for more information on lakes, the 
agency, in 1979, terminated the rulemaking initiated by this proposal 
without taking final action (44 FR 36411, June 22, 1979).
    In the same issue of the Federal Register (44 FR 36411), the agency 
published a notice that announced the agency's intent to repropose 
regulations concerning lakes (the 1979 notice of intent (NOI)). The 
agency also addressed the comments it had received in response to the 
1965 proposal regarding the permanent listing of lakes. Three of the 
five comments on the 1965 proposal recommended revising the regulations 
to provide for the use of more than one previously certified batch of 
color additive in the preparation of lakes for coloring drugs and 
cosmetics. In the 1979 NOI, the agency stated its intention to consider 
this recommendation in developing a new proposal for the permanent 
listing of lakes. The agency also identified the following issues for 
the scientific review of lakes: (1) The definition and nomenclature of 
lakes; (2) the safety of lakes; and (3) the specifications for lakes 
(stability and certification methodology). The agency requested 
information and comments pertaining to these issues.
    The agency received four comments on the 1979 NOI. These included 
two brief responses from manufacturers and two extensive comments from 
trade associations, the International Association of Color 
Manufacturers (IACM) (formerly the Certified Color Manufacturers' 
Association (CCMA)) and the Cosmetic, Toiletry, and Fragrance 
Association, Inc. (CTFA). The issues raised by the agency in the 1979 
NOI, along with the four comments received on that notice, and the 
agency's responses to the comments, are discussed in the following 
sections. This proposal does not, however, address comments related to 
the straight colors that were provisionally listed in 1979 but have 
been denied permanent listing in subsequent rulemakings (FD&C Red No. 3 
(externally applied drug and all cosmetic uses), D&C Red Nos. 8, 9, and 
19, and D&C Orange No. 17).

III. Development of Proposed Actions for Lakes

A. Terminology of Lakes

    The agency is proposing the following changes to the existing 
definitions relating to lakes.
1. Straight Color
    Currently, Sec. 70.3(j) defines the term ``straight color'' as ``a 
color additive listed in parts 73, 74, and 81 of this chapter, and 
includes lakes * * *.'' Thus, the term encompasses all listed color 
additives, including lakes. Current Sec. 70.3(l) defines the term 
``lake'' as ``a straight color extended on a substratum by adsorption, 
coprecipitation, or chemical combination that does not include any 
combination of ingredients made by simple mixing process.'' These two 
regulations, when read together, suggest that a lake may be used as a 
color component of another lake. This implication is inconsistent with 
current regulations for lakes (Secs. 82.51, 82.1051, and 82.2051) and 
with the proposed regulations for lakes in this document, which do not 
allow the synthesis of a lake using another lake as a color component.
    There are other instances in which the existing definition of 
straight color creates confusion. For example, the procedures for 
requesting certification of a batch of a color additive treat straight 
colors (Sec. 80.21(j)(1) (21 CFR 80.21(j)(1)) and lakes 
(Sec. 80.21(j)(2)) separately. Federal Register publications relating 
to color additives also commonly use the term ``straight color'' to 
refer to a color additive other than a lake. For example, the 1979 NOI 
referred to straight colors as distinct from lakes; the agency's 
request for information concerning the usage of FD&C Red No. 3 
requested data on straight colors, lakes, and mixtures (52 FR 44485; 
November 19, 1987). Communications between the agency and industry also 
indicate that the common usage of the term ``straight color'' does not 
ordinarily include the term ``lake.'' To eliminate the confusion 
resulting from the existing definition, the agency is proposing to 
revise the definition for ``straight color.'' As revised, the 
definition would read ``The term `straight color' means a color 
additive that is listed in part 73 or 74 of this chapter, but does not 
include color additive mixtures or lakes.''
2. Listed Color
    As discussed in section III.A.1., the proposed definition of 
``straight color'' would exclude lakes. Therefore, the agency is 
proposing a new term ``listed color'' to refer to any color additive 
(including a lake) listed in part 73 or 74 for any use. By definition, 
the term would not include mixtures, which are not themselves listed 
colors but rather combinations of listed colors. The agency is 
proposing to add the following definition at Sec. 70.3(w): ``The term 
'listed color' means a color additive listed in part 73 or 74 of this 
chapter and includes lakes.''
3. Mixture
    Currently, Sec. 70.3(k) defines the term ``mixture'' as ``a color 
additive made by mixing two or more straight colors, or one or more 
straight colors and one or 

[[Page 8376]]
more diluents.'' The agency is proposing to modify this definition to 
replace the current reference to ``straight color'' with ``listed 
color'' and to clarify that a mixture does not involve a chemical 
reaction between its components. Proposed Sec. 70.3(k) would read ``The 
term `mixture' means a color additive made by mixing two or more listed 
colors, or one or more listed colors and one or more diluents, without 
an accompanying chemical reaction.''
4. Lake
    Currently, Sec. 70.3(l) defines the term ``lake'' as ``a straight 
color extended on a substratum by adsorption, coprecipitation, or 
chemical combination that does not include any combination of 
ingredients made by simple mixing process.'' As discussed in sections 
IV. and V. of this document, the agency is proposing to permit the 
preparation of a lake using more than one straight color. Proposed 
Sec. 70.3(l) would read ``The term `lake' means a color additive made 
by extending one or more straight colors on one or more substrata by 
adsorption, coprecipitation, or chemical combination, but does not 
include mixtures.''
5. Substratum
    Currently, Sec. 70.3(n) defines ``substratum'' as ``the substance 
on which the pure color in a lake is extended.'' This definition 
implies that it is only the pure color that is extended on the 
substratum. However, the data reviewed by the agency on the stability 
of straight colors after laking clearly demonstrate that intermediates 
and subsidiary colors are also extended on the substratum during the 
laking process. Therefore, the agency is proposing to amend the 
definition of substratum to read ``The term `substratum' means the 
substance on which the straight color in a lake is extended.''
6. Precipitant (Basic Radical)
    Although the term ``basic radical'' is not defined in the color 
additive regulations, Secs. 82.51 and 82.1051 use ``basic radical'' to 
denote a substance that may be used to precipitate a lake during its 
manufacture. The agency believes that ``precipitant'' is a more 
descriptive and scientifically accurate term for such a substance. 
``Precipitant'' is the term normally used in technical publications. 
For example, the Condensed Chemical Dictionary (12th ed., 1993) defines 
a lake as a pigment produced by the interaction of an ``organic dye, a 
precipitant, and an absorptive inorganic substrate.'' However, the same 
source contains no definition of ``basic radical.'' The publications of 
trade organizations also use the term ``precipitant'' rather than 
``basic radical'' in discussions of lakes (Ref. 12). Therefore, the 
agency is proposing to use the term ``precipitant'' rather than the 
term ``basic radical'' in new Secs. 74.50 and 74.1050. However, the 
agency is not proposing any formal definition of ``precipitant'' in 
Sec. 70.3.
7. Repack
    Currently, Sec. 70.3 does not define the term ``repack.'' However, 
repacks are one of the four forms of color additive (in addition to 
straight colors, lakes, and mixtures) that are certified under the 
procedures in part 80. The other three forms of color additive are 
defined in Sec. 70.3. Therefore, the agency tentatively concludes that 
a definition of repack should be added to Sec. 70.3. Proposed 
Sec. 70.3(x) would read ``The term `repack' means all or a portion of a 
batch of certified color additive that has been sealed in accordance 
with Sec. 70.20 and labeled in accordance with Sec. 70.25, but has been 
either opened for repackaging without further processing, or relabeled 
for shipment or delivery, by a person other than the person to whom the 
certificate or acceptance of a notice claiming certification for the 
batch was issued.'' Under Sec. 80.32(d), such repackaging or relabeling 
results in the expiration of the certificate, and the batch therefore 
ceases to be a certified batch. A repack may be certified under the 
procedures in part 80 at a lower fee than for the original batch 
(Sec. 80.10(b)). The agency notes that if a batch or portion of a batch 
is processed in any way, including heating, then it is not a repack and 
must be recertified as a new batch of color additive.

B. Nomenclature of Lakes

    The current nomenclature system for lakes is described in 
Secs. 82.51(b), 82.1051(b) and 82.2051(b). These regulations specify 
that the listed name of a lake is formed from: (1) The listed name of 
the color from which the lake is prepared; (2) the name of the cation 
precipitant combined in such color; and (3) the word ``lake.'' This 
system of nomenclature identifies the color additive as a lake and 
specifies the straight-color component of the lake and the cation 
precipitant used to prepare the lake. However, the name of a lake does 
not identify the substrata used to prepare the lake. Because only one 
substratum (alumina) is permitted in lakes for food use, this system 
presents no identity problems for these lakes. However, under the 
current nomenclature system, lakes listed for drug and cosmetic use are 
not fully identified, because such lakes may contain a variety of 
substrata. Thus, lakes produced from a common straight color and 
cation, but different substrata, are identified with the same name. For 
example, two lakes of D&C Red No. 21, one prepared with the cation 
aluminum and the substratum alumina, the other with the cation aluminum 
and the substrata alumina and titanium dioxide, are both named ``D&C 
Red No. 21 Aluminum Lake.''
    In the 1979 NOI, the agency described this problem with the current 
nomenclature system and stated its intention to modify the nomenclature 
system to include the substrata in the name of the lake. The agency 
received comments from the IACM and CTFA supporting inclusion of 
substrata in the name of a lake for the purpose of more accurately 
identifying the listed color additive. As explained above, although 
omitting the substratum from the name of a lake for food use presents 
no problems, omitting the substratum from the name of a lake restricted 
to drug or cosmetic use could cause confusion as to the identity of the 
lake. However, as the same batch of lake may be used for a food, a 
drug, or a cosmetic (if the lake is listed for all three uses), the 
agency tentatively finds that use of a single nomenclature system to 
identify all lakes would present the least overall confusion to users 
of these color additives. Use of a uniform nomenclature system for all 
lakes is also desirable because it avoids the necessity for 
manufacturers of lakes to provide different labels for packages of the 
same lake. Therefore, the agency is proposing that the same 
nomenclature system be used for all lakes.
    Therefore, the agency is proposing to modify the nomenclature of 
lakes by requiring the inclusion of the identity of substrata in the 
name of a lake. The proposed nomenclature system would construct the 
name of a lake from the name(s) of the straight colors present in the 
lake (in descending order of predominance), followed by the names of 
the cations of the precipitants, and followed by the words ``Lake on 
________ and ________'' (inserting the listed names of the substrata in 
descending order of predominance). For example, the name of a lake 
prepared by the extension of D&C Red No. 27 and D&C Orange No. 5 on 
alumina and titanium dioxide using aluminum chloride and calcium 
chloride as precipitants would be ``D&C Red No. 27 and D&C Orange No. 5 
Aluminum Calcium Lake on Alumina and Titanium Dioxide.''
    Currently, Sec. 82.1051(b)(1) provides that the name of a D&C lake 
prepared 

[[Page 8377]]
from an FD&C color shall be formed from the ``listed name of the color 
from which the lake is prepared, except that if such name contains the 
symbol `FD&C' such symbol shall be changed to `D&C'.'' For example, the 
name of the lake formed from FD&C Yellow No. 5, rosin, and zirconium 
cation is D&C Yellow No. 5 zirconium lake. The agency notes that the 
use of the FD&C, D&C, and Ext. D&C prefixes to designate the approved 
uses of colors originated in the 1939 listings of coal tar colors, 
including lakes (4 FR 1922) and was carried over into the provisional 
listing of these color additives in 1960 (25 FR 9759). The permanently 
listed straight colors retained the names under which they were 
provisionally listed, although the prefixes no longer accurately 
reflected the approved uses in some cases. For example, FD&C Red No. 4 
is permitted for use only in externally applied drug and cosmetic 
products.
    The agency is not proposing any action in this rulemaking to change 
the names of the color additives whose food, drug, or cosmetic use is 
no longer correctly designated by their FD&C or D&C prefix. However, 
the agency has tentatively decided not to continue the current system 
described in Sec. 82.1051(b)(1), in which the prefix `FD&C' is changed 
to `D&C' when naming lakes for drug or cosmetic use that have been 
prepared from straight colors that contain the `FD&C' prefix in their 
name. The agency tentatively concludes that continuation of this 
nomenclature provision is unnecessary to identify the approved uses of 
the lake and could be confusing to users of lakes. As discussed above, 
the designation `D&C' does not always accurately describe the uses of 
the lake. Furthermore, under Sec. 70.25, the label of the color 
additive must contain a declaration of the permitted uses of the lake. 
Finally, because the proposed procedure for certification of lakes (see 
section VI.B. of this document) would rely on the certificate for the 
straight color used to prepare the lake, the agency believes that the 
name of the lake should accurately identify the certified straight 
color on which the certification of the lake is based. For example, 
under the proposed certification procedure for lakes, the certificate 
for the straight color in the lake cited above would be for ``FD&C 
Yellow No. 5,'' not ``D&C Yellow No. 5.''
    In the 1979 NOI, the agency also requested comments to address an 
inconsistency in the current system of nomenclature; namely, that 
certain lakes of identical composition may have different names. For 
example, FD&C Blue No. 1 and D&C Blue No. 4 are two separately listed 
straight colors that are different salt forms of the same dye. (FD&C 
Blue No. 1 is the disodium salt and D&C Blue No. 4 is the diammonium 
salt of a triphenylmethane derivative.) During the laking process the 
accompanying cation in the straight color is replaced by the 
precipitant cation. Thus, the lakes of these two straight colors, 
prepared from the same substrata and precipitants, are chemically 
identical. However, they have different names. For example, under the 
current nomenclature system, the aluminum lakes on alumina of these two 
straight colors are named ``FD&C Blue No. 1 Aluminum Lake'' and ``D&C 
Blue No. 4 Aluminum Lake.'' (Under the proposed system, they would be 
named ``FD&C Blue No. 1 Aluminum Lake on Alumina'' and ``D&C Blue No. 4 
Aluminum Lake on Alumina,'' respectively.)
    In its comment on the 1979 NOI, CTFA agreed with the agency's 
assessment of this nomenclature problem. However, the comment suggested 
that this and other problematic aspects of the current system of 
nomenclature are better viewed as problems with the general 
nomenclature of listed colors, not problems specific to lakes.
    The agency agrees with CTFA's comment that these issues concerning 
the nomenclature of lakes are really issues related to the general 
nomenclature of listed colors. Therefore, the agency is not proposing 
any modifications in the nomenclature of lakes to address these issues, 
which are outside the scope of this rulemaking.
    Under this proposal, the nomenclature proposed in this section 
would be used for two purposes: (1) To prescribe the listed name of the 
lake, because the agency is proposing to issue umbrella regulations for 
lakes rather than an individual regulation for each listed lake; (2) to 
identify the color additive on the labels of lakes that are packaged 
for sale to manufacturers of foods, drugs, and cosmetics to be used in 
coloring those products. The agency notes that lakes are also required 
to be declared as ingredients on the label of foods and cosmetics. 
Section VI.C.3. of this document describes the simplified nomenclature 
system that FDA is proposing for ingredient labeling of lakes on food 
and cosmetic labels.

                Table 1.--Current and Proposed Regulatory Status of Straight Colors Used in Lakes               
----------------------------------------------------------------------------------------------------------------
                      Current listings                                        Proposed listings                 
----------------------------------------------------------------------------------------------------------------
                                                               Proposed regulatory                              
     Current regulatory status           Straight color              status                 Straight color      
----------------------------------------------------------------------------------------------------------------
Permanently listed: Part 74          FD&C Red No. 40.......  Permanently listed:     FD&C Blue No. 1, FD&C Blue 
 (Subpart A--Foods, Subpart B--                               Part 74 (Subpart A--    No. 2, FD&C Green No. 3,  
 Drugs and Subpart C--Cosmetics).                             Foods (Sec.  74.50)).   FD&C Red No. 40, FD&C     
                                                                                      Yellow No. 5, FD&C Yellow 
                                                                                      No. 6.                    
Provisionally listed:                                                                                           
    Part 82 (Subpart B--Foods,       FD&C Blue No. 1, FD&C   (Subpart B--Drugs       FD&C Blue No.1, FD&C Blue  
     Drugs, and Cosmetics).           Blue No. 2, FD&C        (Sec.  74.1050) and     No. 2 (drugs only), FD&C  
                                      Green No. 3, FD&C       Subpart C--Cosmetics    Green No. 3, FD&C Yellow  
                                      Yellow No. 5, FD&C      (Sec.  74.2050))..      No. 5, FD&C Yellow No. 6, 
                                      Yellow No. 6, FD&C                              FD&C Red No. 4, FD&C Red  
                                      Red No. 4.                                      No. 40, D&C Blue No. 4,   
                                                                                      D&C Orange No. 4, D&C     
                                                                                      Orange No. 5, D&C Orange  
                                                                                      No. 10, D&C Red No. 6, D&C
                                                                                      Red No. 7, D&C Red No. 21,
                                                                                      D&C Red No. 22, D&C Red   
                                                                                      No. 27, D&C Red No. 28,   
                                                                                      D&C Red No. 31, D&C Red   
                                                                                      No. 33, D&C Red No. 34,   
                                                                                      D&C Yellow No. 10.        

[[Page 8378]]
                                                                                                                
    (Subpart C--Drugs and            FD&C Blue No. 1, FD&C   Listing Terminated      D&C Green No. 6, D&C Red   
     Cosmetics).                      Blue No. 2, FD&C        (Does not form lakes).  No. 17, D&C Red No. 30,   
                                      Green No. 3, FD&C                               D&C Red No. 36, D&C Violet
                                      Yellow No. 5, FD&C                              No. 2.                    
                                      Yellow No. 6, FD&C                                                        
                                      Red No. 4, FD&C Blue                                                      
                                      No. 4, FD&C Green No.                                                     
                                      5, FD&C Green No. 6,                                                      
                                      FD&C Orange No. 4,                                                        
                                      FD&C Orange No. 5,                                                        
                                      FD&C Orange No. 10,                                                       
                                      FD&C Orange No. 11,                                                       
                                      FD&C Orange No. 6,                                                        
                                      FD&C Red No. 7, FD&C                                                      
                                      Red No. 17, FD&C Red                                                      
                                      No. 21, FD&C Red No.                                                      
                                      22, FD&C Red No. 27,                                                      
                                      FD&C Red No. 28, FD&C                                                     
                                      Red No. 30, FD&C Red                                                      
                                      No. 31, FD&C Red No.                                                      
                                      33, FD&C Red No. 34,                                                      
                                      FD&C Red No. 36, FD&C                                                     
                                      Violet No. 2, FD&C                                                        
                                      Yellow No. 7, FD&C                                                        
                                      Yellow No. 8, FD&C                                                        
                                      Yellow No. 10.                                                            
                                                             Listing Terminated (No  D&C Green No. 5, D&C Orange
                                                              batches certified):.    No. 11, D&C Yellow No. 7, 
                                                                                      D&C Yellow No. 8.         
    (Subpart D-- Externally Applied  Ext. D&C Yellow No. 7.  Listing Terminated (No  Ext. D&C Yellow No. 7.     
     Drugs and Cosmetics).                                    confirmation of                                   
                                                              stability during                                  
                                                              laking).                                          
----------------------------------------------------------------------------------------------------------------



C. Issues Relating to Definition of Lakes and Termination of Certain 
Provisional Listings

1. Straight Colors
    A summary of the current and proposed regulatory status of straight 
colors for use in lakes is given in Table 1.
    CTFA's comments on the 1979 NOI include information on the chemical 
structure of the straight colors currently listed for use in lakes. 
Based on its evaluation of these data and other information from the 
published literature, the agency tentatively concludes that, to form a 
lake, a straight color must contain a salt-forming group (i.e., a salt, 
an acid, or a lactone group) as part of its chemical structure. The 
agency finds that the following straight colors listed in part 82 
contain a salt- forming group and thus are capable of forming a lake: 
FD&C Red No. 4, D&C Red No. 6, D&C Red No. 7, D&C Red No. 21, D&C Red 
No. 22, D&C Red No. 27, D&C Red No. 28, D&C Red No. 31, D&C Red No. 33, 
D&C Red No. 34, FD&C Blue No. 1, FD&C Blue No. 2, D&C Blue No. 4, FD&C 
Green No. 3, D&C Green No. 5, D&C Orange No. 4, D&C Orange No. 5, D&C 
Orange No. 10, D&C Orange No. 11, FD&C Yellow No. 5, FD&C Yellow No. 6, 
D&C Yellow No. 7, D&C Yellow No. 8, D&C Yellow No. 10, and Ext. D&C 
Yellow No. 7.
    However, based on the same information, the agency notes that the 
following five straight colors listed in part 82 do not contain a salt-
forming group as part of their chemical structure and therefore cannot 
form lakes: D&C Red No. 17, D&C Red No. 30, D&C Red No. 36, D&C Violet 
No. 2, and D&C Green No. 6. CTFA's comment on the 1979 NOI also stated 
that D&C Green No. 6 does not form a lake. Therefore, the agency 
tentatively concludes that combinations of these straight colors with 
substrata do not meet the definition of lake in Sec. 70.3(l). 
Consequently, the agency is proposing to terminate the listing of D&C 
Red No. 17, D&C Red No. 30, D&C Red No. 36, D&C Violet No. 2, and D&C 
Green No. 6 as components of lakes. This proposed action would not 
affect the listing of these color additives as straight colors. Under 
the proposal, combinations of these straight colors with substrata that 
are approved diluents or approved color additives would be color 
additive mixtures rather than lakes. Such mixtures would be exempt from 
certification under Sec. 80.35(b).
2. Diluents in Color Additive Mixtures for Cosmetic and Drug Use
    a. Cosmetics. The agency notes that its proposed action to 
terminate the listing of five straight colors as components of lakes 
would not affect the use of these straight colors in cosmetic products. 
Combinations of D&C Red No. 17, D&C Red No. 30, D&C Red No. 36, D&C 
Violet No. 2, or D&C Green No. 6 with substrata listed in Sec. 82.1051 
are color additive mixtures as defined in Sec. 70.3(k), and the 
``substrata'' used in these combinations are diluents as defined in 
Sec. 70.3(m). Because no regulation limits the diluents that may be 
used in color additive mixtures intended for use in cosmetic products, 
the proposed action to terminate the listing of D&C Red No. 17, D&C Red 
No. 30, D&C Red No. 36, D&C Violet No. 2, and D&C Green No. 6 for use 
in lakes would not affect their use in cosmetics as color additive 
mixtures containing, as diluents, the substances now listed as 
substrata in Sec. 82.1051 (alumina, blanc fixe, gloss white, clay, 
titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, and 
calcium carbonate).
    b. Drugs. The proposed action to terminate the listing of D&C Red 
No. 17, D&C Red No. 30, D&C Red No. 36, D&C 

[[Page 8379]]
Violet No. 2, and D&C Green No. 6 for use in lakes would not affect 
their use in drugs as color additive mixtures containing the following 
substrata now listed in Sec. 82.1051: Alumina, calcium carbonate, talc, 
titanium dioxide, and zinc oxide. Alumina, calcium carbonate, talc, and 
titanium dioxide are listed in Secs. 73.1010, 73.1070, 73.1550, and 
73.1575, respectively, as color additives exempt from certification for 
use in drugs generally (ingested drugs and externally applied drugs). 
Therefore, combinations of these substances with D&C Red No. 17, D&C 
Red No. 30, D&C Red No. 36, D&C Violet No. 2, and D&C Green No. 6 are 
permitted as color additive mixtures under existing regulations. Zinc 
oxide is listed in Sec. 73.1991 as a color additive exempt from 
certification for use in coloring externally applied drugs. In 
addition, zinc oxide is generally recognized as safe (GRAS) for use as 
a dietary supplement (Sec. 182.5991 (21 CFR 182.5991)) and as a 
nutrient in food (Sec. 182.8991 (21 CFR 182.8991)). Section 73.1001 
permits the use of substances listed in Sec. 73.1(a) as diluents in 
color additive mixtures for ingested drug use. In turn, Sec. 73.1(a) 
permits the use of substances that are GRAS under section 201(s) of the 
act (21 U.S.C. 321(s)). Therefore, the agency concludes that zinc oxide 
may be used with D&C Red No. 17, D&C Red No. 30, D&C Red No. 36, D&C 
Violet No. 2, and D&C Green No. 6 either as an approved diluent in 
color additive mixtures for coloring ingested drugs or as a straight-
color ingredient in color additive mixtures for coloring externally 
applied drugs.
    Rosin is currently listed in Sec. 73.1(b)(1)(i) as a diluent in 
color additive mixtures for use in inks for marking food supplements in 
tablet form, gum, and confectionery, and by reference, for use under 
Sec. 73.1001(a)(2) in inks for branding pharmaceutical forms. In its 
review of the safety of the substrata currently listed in Sec. 82.1051 
(see section V.A.2.j. of this document), the agency determined that the 
ingested uses of rosin are safe. However, in this same review, the 
agency stated that it was aware of literature reports of dermal 
irritation due to rosin (Ref. 13). Recently submitted data on human 
skin sensitization and photoreaction to commercially available cosmetic 
products colored with rosin lakes (Ref. 14) establish that lakes 
containing rosin as a substratum are safe for externally applied drugs 
and cosmetics. However, the rosin present in lakes, where it is a 
component of an insoluble pigment, is not identical to free rosin 
present as a diluent in color additive mixtures. Therefore, the agency 
tentatively concludes that the data submitted on the safety of 
externally applied rosin lakes do not resolve the safety issues 
presented by the use of free rosin as a diluent in externally applied 
drug products, such as the risk of allergic contact dermatitis and 
occupational asthma.
    Based on its safety review of rosin, the agency is proposing to 
amend Sec. 73.1001 to list rosin as a diluent in color additive 
mixtures for ingested drug use only. However, if the agency receives 
information that adequately supports the safety of rosin as a diluent 
in color additive mixtures for use in externally applied drugs, the 
agency will consider listing rosin as a diluent for color additive 
mixtures for both ingested and externally applied drugs. Anyone 
interested in the listing of rosin for such use should submit 
information on the identity, specifications, and dermal safety of the 
rosin for which listing is sought.
    The current regulations do not allow for the use of aluminum 
benzoate, blanc fixe, clay, and gloss white as diluents in color 
additive mixtures for drug use, because only the diluents provided for 
in Sec. 73.1001 may be used in color additive mixtures for coloring 
drugs. However, FDA has evaluated the safety of these substances, or 
the materials used to make them, as part of its review of substrata in 
lakes for drug and cosmetic use in section V.A.2. of this document. 
This review included data on the ingested and dermal uses of barium 
sulfate (blanc fixe), kaolin (clay), benzoic acid, and benzoates. 
Specifically, the agency considered literature reviews of aluminum 
salts, barium sulfate, kaolin and bentonite (a silicate); information 
from the color additive petitions for use of certain aluminum lakes in 
eye-area cosmetics; and safety reviews of aluminum compounds, benzoic 
acid and benzoates, and kaolin and bentonite as food ingredients. These 
safety reviews were conducted by the Select Committee on GRAS 
Substances of the Federation of American Societies for Experimental 
Biology and the Joint Food and Agriculture Organization (FAO)/World 
Health Organization (WHO) Expert Committee on Food Additives.
    Based on its review, which is discussed in section V.A.2. of this 
document, the agency tentatively concludes that barium sulfate (blanc 
fixe), aluminum benzoate, and kaolin (clay) are safe for use as 
diluents in color additive mixtures for drug use. Therefore, as part of 
its disposition of the provisional listings in part 82, the agency is 
proposing to amend Sec. 73.1001 to list barium sulfate, aluminum 
benzoate, and kaolin as diluents that may be safely used in color 
additive mixtures exempt from certification that are intended for use 
in ingested and externally applied drugs. The agency notes that gloss 
white is a mixture of alumina and barium sulfate and thus would be 
permitted for any use in color additive mixtures for which both alumina 
and barium sulfate are permitted.
    For the reasons discussed above, the agency tentatively concludes 
that the proposed action to terminate the listing of D&C Red No. 17, 
D&C Red No. 30, D&C Red No. 36, D&C Violet No. 2, and D&C Green No. 6 
as components of lakes would not affect their use in drugs as color 
additive mixtures containing alumina, calcium carbonate, kaolin (clay), 
talc, zinc oxide, barium sulfate (blanc fixe), aluminum benzoate, 
titanium dioxide, gloss white, or rosin (ingested drugs only). However, 
the proposed termination would mean that those straight colors could no 
longer be used in externally applied drugs as color additive mixtures 
containing rosin, unless the agency receives data that establish the 
safety of rosin as a diluent for externally applied uses.
3. Extended Toners
    In the 1979 NOI, the agency requested information to identify 
certain insoluble color additives, commercially described as extended 
toners, that are classified as lakes under part 82. The agency 
requested comments on the need to modify existing regulations or to 
promulgate new regulations to address these color additives. FDA noted 
its intent, in the absence of comments to the contrary, to exclude 
these products from the definition of lakes.
    CTFA's comment on the 1979 NOI provided information that identified 
the composition of extended toners and of related insoluble color 
additives known as resinated toners, extended resinated toners, and 
toners. The comment requested revision of the definitions in 21 CFR 
70.3 to better describe these substances. The agency has evaluated the 
available information and determined that the color additives described 
commercially as toners, resinated toners, extended toners, and extended 
resinated toners are not lakes. These substances are either water- 
insoluble straight colors or mixtures of water-insoluble straight 
colors with insoluble diluents. Therefore, the agency tentatively 
concludes that no new or modified regulations are needed to address 
toners, resinated toners, extended toners, and extended resinated 

[[Page 8380]]
toners because these substances are mixtures as defined in 
Sec. 70.3(k), and the ``substrata'' used in these combinations are 
diluents, as defined in Sec. 70.3(m).
    The proposed reclassification of toners, resinated toners, extended 
toners, and extended resinated toners as color additive mixtures 
containing as diluents the ingredients now listed as substrata in 
Sec. 82.1051 would not affect their use in drugs, because, as discussed 
in section III.C.2. of this document, these substrata (except rosin for 
use in externally applied drugs) are listed as GRAS in part 182, 184, 
or 186 (21 CFR part 182, 184, or 186), approved as color additives for 
drug use in part 73, or the agency is proposing to list them in 
Sec. 73.1001 as diluents in color additive mixtures for drug use. 
Because there is no regulation that limits the diluents that can be 
used in color additive mixtures for cosmetic use, the proposed 
reclassification of this group of color additives from lakes to color 
additive mixtures would not affect their use in cosmetics.
4. Requests for Listing of Additional Lake Components
    CTFA's comments on the 1979 NOI included a request that FDA 
authorize for use in lakes the following straight colors: D&C Brown No. 
1, D&C Green No. 8, and Ext. D&C Violet No. 2. These three straight 
colors are currently listed in part 74 for cosmetic use. In addition, 
D&C Green No. 8 is currently listed in part 74 for drug use. However, 
the agency notes that these straight colors are not listed either 
permanently in part 74 or provisionally in part 82 for use in preparing 
lakes. Therefore, the agency tentatively concludes that consideration 
of these straight colors for use in lakes is outside the scope of this 
proposal, which addresses only the provisionally listed lakes and their 
components. Interested persons may submit a color additive petition 
under Sec. 71.1 (21 CFR 71.1) to amend the regulations to permit the 
use of these straight colors in lakes.
    CTFA's comments on the 1979 NOI also suggested that bismuth 
oxychloride and mica should be listed as acceptable substrata in lakes 
for coloring drugs and cosmetics. IACM's comments requested the listing 
of titanium dioxide as a substratum for lakes for coloring foods. 
However, bismuth oxychloride and mica are not provisionally listed in 
part 82 as substrata in lakes for drug or cosmetic use, and titanium 
dioxide is not provisionally listed in part 82 as a substratum in lakes 
for food use. Therefore, the agency tentatively concludes that 
consideration of the requested uses of these substances as substrata in 
lakes is outside the scope of this rulemaking, which addresses 
provisionally listed lakes and their components. Interested persons may 
submit a color additive petition under Sec. 71.1 to amend the 
regulations to permit use of these substances in lakes.
5. Definition of Lakes Versus Mixtures
    CTFA's comments on the 1979 NOI noted that the straight-color 
component of a lake, and not the substratum, provides the coloring 
effect and, therefore, requested that the agency classify lakes as 
color additive mixtures and list permitted substrata as diluents for 
color additive mixtures.
    As discussed in section III.C.1. of this document, the agency 
agrees that combinations of non-salt-forming straight colors with 
substrata should be classified as mixtures rather than lakes. As to 
salt-forming straight colors, however, the agency disagrees with CTFA's 
interpretation. Lakes are very different from color additive mixtures 
because of the chemical reaction required to produce a lake. The agency 
finds that, under both the current and proposed definitions of a lake, 
the substratum is an integral part of the lake. In a mixture, there is 
little if any chemical interaction between the components, which 
function as separate ingredients. In the preparation of a lake, 
however, there is a chemical reaction between the components, and the 
physical properties of the resulting lake are very different from those 
of the straight-color component (see section I. of this document). 
Therefore, the agency tentatively concludes that lakes are not mixtures 
and that substrata used to prepare a lake are not separate ingredients, 
but are components of the finished color additive.
6. Pre-Amendments Certification of Provisionally Listed Lakes
    As discussed in section II.A. of this document, the transitional 
provisions of the 1960 amendments limited the provisional listing of 
certifiable color additives to those for which at least one batch had 
been certified prior to July 12, 1960, the enactment date of the 1960 
amendments. In establishing the provisional list (25 FR 9759), FDA 
removed 32 colors from listing because the agency had never certified 
any batches of these colors. In preparing this document, the agency 
reviewed its batch certification records to confirm that each straight 
color, substratum, and precipitant included in the provisional listing 
regulations for lakes was a component of at least one batch of a lake 
certified between 1939 and July 12, 1960.
    a. Straight Colors. The agency's search of color certification 
records between 1939 and the enactment of the 1960 amendments 
established that the agency did not certify any batches of lakes of D&C 
Orange No. 11, D&C Yellow No. 7, D&C Yellow No. 8, or D&C Green No. 5 
during that time. The agency tentatively concludes that its original 
provisional listing of these color additives for use in lakes for drugs 
or cosmetics was therefore incorrect. Accordingly, the agency is 
proposing to terminate the provisional listings of D&C Orange No. 11, 
D&C Yellow No. 7, D&C Yellow No. 8, and D&C Green No. 5 as components 
of lakes for use in drugs or cosmetics. Any future consideration of the 
use of these color additives as components of lakes would be through 
the color additive petition process (Sec. 71.1).
    b. Substrata. The agency's color certification records show that 
all of the substrata listed in Secs. 82.51, 82.1051, and 82.2051, 
except calcium carbonate, have been in continuous use in lakes because 
certification was initiated in 1939 (Ref. 15). The agency added calcium 
carbonate to the list of permitted substrata in 1959 (24 FR 3818) and 
certified at least one batch of a lake containing this substratum for 
drug or cosmetic use before the enactment of the 1960 amendments.
    c. Precipitants. Section 82.51 lists two cations (calcium and 
aluminum) as components of precipitants in lakes for food use. The 
agency certified batches of FD&C aluminum lakes before the enactment of 
the 1960 amendments. However, in the 1979 NOI, the agency proposed to 
delete calcium as a listed cation in lakes for food use because the 
agency had never certified any batches of FD&C calcium lakes.
    Comments on the 1979 NOI from IACM and CTFA requested the agency 
not to take this action. However, because these comments provided no 
information to document agency certification of any batches of FD&C 
calcium lakes before the enactment of the 1960 amendments, the agency 
tentatively concludes that its original provisional listing of these 
lakes was incorrect. Therefore, the agency is proposing to terminate 
the provisional listing of calcium as a precipitant in the preparation 
of lakes for food use. Any future consideration of the use of lakes 
containing calcium precipitants for coloring food would be through the 
color additive petition process (Sec. 71.1).
    Sections 82.1051 and 82.2051 list seven cations (sodium, potassium, 
aluminum, barium, calcium, strontium, and zirconium) as components of 
precipitants in lakes for drug or cosmetic use. The agency certified 

[[Page 8381]]
batches of lakes containing each of these seven cations for drug or 
cosmetic use before the enactment of the 1960 amendments.

IV. Safety Review and Proposed Actions for Lakes for Use in Foods

A. Review of Components of Lakes for Use in Foods

    The current regulation for provisionally listed lakes for use in 
foods (21 CFR 82.51) provides for use of the following components in 
such lakes: (1) Certified batches of the straight colors FD&C Blue No. 
1 (21 CFR 82.101), FD&C Blue No. 2 (21 CFR 82.102), FD&C Green No. 3 
(21 CFR 82.203), FD&C Yellow No. 5 (21 CFR 82.705), FD&C Yellow No. 6 
(21 CFR 82.706); (2) the substratum alumina; (3) precipitants 
containing the cations aluminum (Al+3) and calcium (Ca+2). 
Additionally, 21 CFR 74.340 permanently lists lakes of FD&C Red No. 40 
that are prepared as described in 21 CFR 82.51 and that meet the 
specifications and labeling requirements prescribed by Sec. 82.51.
    The identity and specifications for the straight colors used in the 
preparation of the provisionally listed lakes for food use are provided 
in the regulations for the straight-color components of lakes in part 
82, which are cited above. The regulations in part 82 cross-reference 
the permanent listings of the straight colors in part 74. As to 
substrata, Sec. 82.3 defines alumina, but provides no specifications 
for alumina or for the materials used to prepare it in situ. Finally, 
with regard to precipitants, part 82 does not identify or prescribe 
specifications for the precipitants that may be used in the preparation 
of these lakes, other than specifying the cation component and 
providing specifications that limit the level of soluble chlorides and 
sulfates in the lake.
1. Straight Colors
    a. Identity. The agency has already reviewed the identity and 
safety of the straight colors currently permitted as components of 
lakes for food use, either as part of its scientific review of 
provisionally listed straight colors or in response to petitions for 
the review of new color additives. Based on these reviews, the agency 
concluded that FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C 
Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40 are safe for use 
in foods and permanently listed these straight colors in 21 CFR part 
74, subpart A. The agency is proposing to continue to permit the use of 
these straight colors as components of lakes for use in food, subject 
to the proposed requirements discussed below.
    b. Use of previously certified batches. Currently, under 
Sec. 82.51, manufacturers are required to prepare lakes for food use 
from previously certified batches of straight colors. This requirement 
was intended to ensure that the levels of intermediates, subsidiary 
colors, and other impurities in straight colors that are used to 
prepare lakes for food use are within the levels specified in the 
applicable regulations. Impurities in the straight color, especially 
the carcinogenic constituents present in some straight colors, are a 
primary safety concern with the use of these color additives and their 
lakes in food.
    In the 1979 NOI, the agency requested submission of information 
about available methods for the determination of total (free plus 
bound) intermediates, as well as subsidiary colors and other 
impurities, and stated that without appropriate analytical methodology 
it might be necessary to require that all lakes be produced from 
certified batches of straight colors. The agency stated that there was 
no satisfactory analytical method to determine total intermediates in 
lakes. The available methods detected free intermediates but not 
necessarily the intermediates that, like the straight color, are bound 
to the substratum.
    The comments on the 1979 NOI did not provide suitable methodology 
for the analysis of intermediates and other impurities in lakes. CTFA's 
comment stated that these problems could be addressed only through a 
time-consuming and difficult undertaking to develop satisfactory 
analytical methods. The comment suggested that the issue of 
certification methodology should be separated from that of the 
permanent listing of lakes, thus allowing these lakes to be permanently 
listed while the industry and the agency went on to address the issue 
of certification methodology jointly.
    Section 721(b)(5)(A)(iv) of the act provides that in determining 
whether the proposed use of a color additive is safe, the agency must 
consider, among other relevant factors, the availability of any needed 
practicable methods of analysis for determining the identity and 
quantity of intermediates and other impurities contained in the color 
additive. If lakes are prepared from uncertified batches of straight 
colors, the only way to ensure that the intermediates, subsidiary 
colors, and other impurities derived from the straight color do not 
exceed the specification limits for the lake is to analyze the lake 
itself for those impurities. However, as indicated above, the 
analytical methods to accomplish this purpose are not currently 
available. Therefore, the agency tentatively concludes that the lack of 
adequate analytical methods to determine the levels of intermediates 
and other impurities in lakes precludes the agency from prescribing 
conditions of safe use for lakes prepared from uncertified batches of 
straight colors. Accordingly, to ensure the continued safety of lakes 
for food use, the agency is proposing to retain the requirement that 
these lakes be prepared from certified batches of straight colors. As 
discussed in section V.A. of this document, FDA is also proposing to 
require that lakes for use in drugs and cosmetics be prepared from 
certified batches of straight colors.
    c. Stability. In the 1979 NOI, the agency asked for information 
about the chemical stability of straight colors during the laking 
process. The agency stated that if previously certified batches of 
straight colors are used in the preparation of lakes, the levels of 
intermediates and subsidiary colors in these lakes should be 
proportional to those in the original batch of the straight color. 
However, the agency was concerned that the laking process could cause 
an unstable straight color to deteriorate and, consequently, increase 
the levels of intermediates and subsidiary colors.
    The agency requested data to confirm the stability of previously 
certified batches of straight colors during the laking process. The 
agency stated that, if such data were submitted, the agency would not 
require specifications for intermediates and subsidiary colors in lakes 
prepared from certified batches of straight colors. The agency also 
noted the lack of satisfactory methodology for identifying and 
quantifying intermediates and certain other contaminants in many lakes, 
but added that the lack of such methodology does not pose a problem for 
lakes produced from previously certified batches of colors, provided 
that there is no measurable degradation of the color during the laking 
process.
    The straight colors that FDA proposes to permit as components of 
lakes for food use fall into the following four groups, based on 
chemical structure (the Color Index Structural classification (Ref. 
16), as further refined by Marmion (Ref. 17)): Monoazo (FD&C Red No. 
40, FD&C Yellow No. 6); pyrazolone (FD&C Yellow No. 5); 
triphenylmethane (FD&C Blue No. 1, FD&C Green No. 3); and indigoid 
(FD&C Blue No. 2). The FD&C lakes of these straight colors made up 
about 80 percent of the total poundage of lakes certified in fiscal 
year 1995 (FY-95) (Ref. 18). FD&C lakes of three 

[[Page 8382]]
straight colors (FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 
40) made up about 90 percent of the FD&C lakes certified in FY-95. 
Lakes of FD&C Blue No. 1 and FD&C Blue No. 2 made up the remaining 10 
percent. No batches of FD&C Green No. 3 lakes were certified in FY-95. 
Because lakes of monoazo and pyrazolone dyes make up such a high 
proportion of lakes certified, the agency is particularly concerned 
about possible degradation of FD&C lakes of these dyes.
    CTFA submitted data (Ref. 19) to confirm the stability during 
laking on alumina of three straight colors (FD&C Blue No. 1, FD&C Red 
No. 40, and FD&C Yellow No. 5) that represent three of the four 
structural groups. The data presented a comparison of the high 
performance liquid chromatography (HPLC) evaluations of each of five 
samples of FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Blue No. 1 with 
the corresponding lake made from each sample. FDA has evaluated the 
data submitted by CTFA. A quantitative comparison of the levels of 
intermediates and subsidiary colors present in the straight color and 
the corresponding lake confirmed that the levels of intermediates and 
subsidiary colors in the lakes (after adjustment for the percent 
straight color in the lake) did not differ significantly from those in 
the corresponding straight colors (Ref. 20).
    The agency also conducted a brief study on the stability of FD&C 
Blue No. 2 during the laking process (Ref. 21). This study presented a 
comparison of the HPLC evaluations of a sample of a certified batch of 
FD&C Blue No. 2 and a sample of a certified batch of the aluminum lake 
prepared from this batch. A quantitative comparison of the levels of 
intermediates and subsidiary colors present in the straight color and 
the corresponding lake confirmed that the levels of intermediates and 
subsidiary colors in the lake (after adjustment for the percent 
straight color in the lake) did not differ significantly from those in 
the corresponding straight color.
    The data evaluated by the agency provide evidence that lakes of the 
straight colors FD&C Yellow No. 5, FD&C Red No. 40, FD&C Blue No. 1, 
and FD&C Blue No. 2 can be produced without significant degradation of 
the straight color. When produced under conditions of current good 
manufacturing practice (CGMP), these lakes meet the specifications for 
intermediates and subsidiary colors in the straight color, after 
adjustment for total color content of the lake. Although data have not 
been submitted for all of the straight colors FDA proposes to permit as 
components of lakes for food use, the remaining such straight colors 
(FD&C Green No. 3 and FD&C Yellow No. 6) have chemical structures that 
are similar to other straight colors (FD&C Blue No. 1 and FD&C Red No. 
40, respectively) discussed above. The stability of FD&C Yellow No. 6 
aluminum lake, which makes up over 25 percent of the total poundage of 
FD&C lakes certified in FY-95, is also supported by published studies. 
In these studies, the FD&C Yellow No. 6 aluminum lake showed greater 
thermal stability than did FD&C Red No. 40 aluminum lake (Ref. 22), and 
the straight color FD&C Yellow No. 6 was as stable as the straight 
color FD&C Red No. 40 under the pH conditions studied, showing no 
appreciable change over a week's exposure (Ref. 17). The agency 
tentatively finds that because of the similarity of chemical structure, 
the data available for the lakes of FD&C Blue No. 1 and FD&C Red No. 40 
are adequate to confirm the stability of FD&C Green No. 3 and FD&C 
Yellow No. 6, respectively, during the manufacture of lakes in 
accordance with CGMP. In addition, the published data on FD&C Yellow 
No. 6 and its aluminum lake provide corroborative evidence for the 
stability of this straight color during the laking process when 
conducted under conditions consistent with CGMP.
    Based on its previous evaluations of the safety of the straight 
colors that FDA proposes to permit as components of lakes for food use 
and on the scientific evidence that lakes of these straight colors can 
be produced under conditions consistent with CGMP without significant 
degradation of the straight color, the agency now tentatively concludes 
that certified batches of FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green 
No. 3, FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40 are 
safe for use as components of lakes for food use that are prepared 
under conditions of CGMP. Therefore, the agency is proposing to permit 
certified batches of these straight colors as components of lakes for 
food use in Sec. 74.50.
    The agency is not, however, proposing to establish any definition 
of CGMP for the preparation of lakes for food use. FDA recognizes that 
CGMP for laking will vary with the straight color used, may include a 
variety of combinations of conditions, and may change over time with 
the introduction of new combinations of conditions. The agency's 
regulatory goal is to protect the public health by assuring that laking 
is conducted in a manner such that no significant degradation of the 
straight color occurs, not to prescribe the details of industry 
practice. Safety issues relating to the use of CGMP in preparing lakes 
are discussed further in sections IV.B.5 and IV.C. of this document.
    d. Use of more than one straight color in a lake. The agency also 
tentatively concludes that the current prohibition on the use of more 
than one straight color in a lake is unnecessary. This prohibition was 
instituted as part of the original listing of lakes as certified colors 
in 1939 (4 FR 1922, 4 FR 3931, and 5 FR 1138). At that time, the 
regulations did not require that lakes be prepared from previously 
certified batches of straight color, and the only food use for which 
lakes were listed was for dyeing eggs in the shell. The requirement 
that lakes for food use be prepared from previously certified batches 
of straight color was initiated in 1959, when the regulations were 
amended to permit, for the first time, the use of certain lakes in 
foods generally (24 FR 3818 and 24 FR 5302). The agency now tentatively 
concludes that, because of the proposed requirement that certified 
batches of straight colors be used in preparing all lakes, the evidence 
for the stability of straight colors during the laking process, and the 
proposed certification requirement for lakes (discussed in section 
IV.C. of this document), the prohibition against the use of more than 
one straight color to make a lake is unnecessary. Therefore, the agency 
is proposing to permit the preparation of a lake from certified batches 
of more than one straight color.
2. Substratum--Alumina
    Alumina is the only substratum provisionally listed for lakes for 
food use. Section 82.3(g) defines alumina as ``a suspension in water of 
precipitated aluminum hydroxide'' but prescribes no quality 
requirements for alumina substratum. This definition covers both 
preformed (precipitated and dried) alumina that is subsequently 
suspended in water and alumina that is prepared in situ, without 
subsequent recovery and drying.
    As noted in section I. of this document, alumina may be prepared in 
situ from aluminum sulfate and sodium hydroxide or sodium carbonate 
during the manufacture of lakes. Aluminum sulfate is GRAS for food use 
(Sec. 182.1125) and is subject to the specifications in the Food 
Chemicals Codex 2d. ed. (1972) (Sec. 170.30(h)(1) (21 CFR 
170.30(h)(1))). Sodium carbonate and sodium hydroxide are affirmed as 
GRAS for food use (Secs. 184.1742 and 184.1763, respectively) and are 
required 

[[Page 8383]]
to meet the specifications in the Food Chemicals Codex, 3d. ed. (1981).
    In addition, Sec. 73.1010 lists alumina (dried aluminum hydroxide) 
as a color additive for use in drugs and provides identity and 
specifications for alumina as a color additive. The agency tentatively 
concludes that, although the listed use of alumina (dried aluminum 
hydroxide) is for coloring drug products, alumina that meets the 
identity and quality requirements in Sec. 73.1010 (a)(1) and (b) is 
safe as a substratum for lakes for food use (Ref. 13).
    The agency has evaluated the available data relating to the safety 
of aluminum salts. These data included literature reviews, information 
from a color additive petition for use of several aluminum lakes on 
alumina in eye-area cosmetics, and safety reviews of aluminum compounds 
(including aluminum salts) as food ingredients by the Select Committee 
on GRAS Substances of the Federation of American Societies for 
Experimental Biology and the Joint FAO/WHO Expert Committee of Food 
Additives. Based on this evaluation, the agency tentatively concludes 
that alumina conforming to the identity and quality requirements set 
forth in Sec. 73.1010 (a)(1) and (b) (Refs. 13, 23, and 24) is safe for 
use as a substratum in lakes for food use. The agency also tentatively 
concludes that alumina prepared from aluminum sulfate and sodium 
carbonate or sodium hydroxide that meet the requirements for these 
compounds in the Food Chemicals Codex 2d ed. (1971) (aluminum sulfate) 
or 3d ed. (1981) (sodium carbonate and sodium hydroxide) is safe as a 
component of lakes for food use.
3. Precipitants
    a. Aluminum cation (Al+3). In its safety review of alumina 
(see section IV.A.2. of this document), the agency evaluated the safety 
of the use of the aluminum salts (salts containing the aluminum cation 
(Al+3)). Based on this safety review, the agency tentatively 
concluded that the use of alumina as a substratum in lakes is safe. 
Based on the same data, the agency also tentatively concludes that the 
use of the aluminum cation as a component of precipitants used in the 
preparation of lakes for food use is safe (Ref. 13, 23, and 24). 
Aluminum cation is added as a precipitant with an accompanying anion. 
If an aluminum salt is added as a precipitant, the anion is added as 
part of the salt. Alternatively, if aluminum oxide or hydroxide is used 
as a precipitant, the anion is added as an acid to ensure the 
solubility of the aluminum cation to function as a precipitant. The 
anions that the agency proposes to permit for use in lakes are 
discussed in section IV.A.3.c. of this document.
    The agency is not proposing to establish quality requirements for 
precipitants used in the preparation of lakes for food use. The agency 
recognizes that a variety of precipitant ingredients can be used to 
produce the aluminum cation that functions as a precipitant in lakes 
for food use. Furthermore, the agency does not anticipate that the use 
of precipitant ingredients that form the aluminum cation, under 
conditions consistent with CGMP, would introduce contaminants that 
require limitation by specifications for the precipitant ingredients. 
Precipitants are used at low levels (a small percentage of the total 
batch weight) and, by virtue of their function in the laking process, 
are always water-soluble cations. Because lakes are washed when 
prepared in accordance with CGMP, the agency anticipates that only low 
levels of water-soluble contaminants will remain in the finished lake. 
The only possible concern would be the presence of heavy metals 
deriving from contaminants in the precipitants. To address this 
potential problem, as discussed below, the proposed specifications for 
lakes will limit the levels of heavy metal contaminants permitted in 
the end product. Therefore, the agency tentatively concludes that 
quality requirements for the ingredients used to form precipitants in 
lakes for food use are unnecessary.
    b. Calcium cation (Ca+2). As discussed in section III.C.6.c. 
of this document, the agency is proposing to terminate the listing of 
calcium as a cation in lakes for food use because calcium lakes were 
not used in food in 1960 and thus should not have been provisionally 
listed. Any future consideration of the use of calcium lakes for 
coloring foods would be through the color additive petition process 
(Sec. 71.1).
    c. Accompanying anions. The use of the aluminum cation in 
preparation of lakes results in the formation of chloride or sulfate 
anions. Chloride and sulfate are components of many food ingredients 
that the agency has listed or affirmed as GRAS for general food use 
(for example: Aluminum sulfate, Sec. 182.1125; calcium sulfate, 
Sec. 184.1230; table salt (sodium chloride), Sec. 182.1(a); potassium 
chloride, Sec. 184.1622). In the safety reviews conducted as part of 
the GRAS rulemakings for these ingredients, the agency found that 
ingestion of chloride and sulfate (in the presence of the accompanying 
cation) was safe at levels that vastly exceed possible levels of 
exposure to these anions as components of lakes. Therefore, the agency 
tentatively concludes that the presence of these anions in lakes for 
food use is safe when CGMP is observed (Ref. 13).

B. Specifications for Lakes for Use in Foods

1. Intermediates and Other Impurities Derived From Straight Colors
    A typical straight color contains, in addition to the primary color 
component, intermediates and subsidiary colors. Intermediates are 
unreacted starting materials used to synthesize the primary color. 
Subsidiary colors are colored by-products of the synthesis of the 
primary color. As discussed in section IV.A.1.b. of this document, the 
agency is proposing to require that lakes be prepared from certified 
batches of straight color. The regulations for straight colors contain 
specifications that limit the levels of intermediates and subsidiary 
colors that may be present in the straight color. In this proposal, the 
agency has also tentatively concluded that the straight colors in lakes 
for food use do not degrade significantly during preparation of the 
lakes under conditions consistent with CGMP. Therefore, the agency 
tentatively concludes that the specifications for intermediates and 
subsidiary colors in straight colors are sufficient to ensure the 
safety of lakes prepared from certified batches of straight colors and 
that separate specifications for intermediates and subsidiary colors in 
lakes are unnecessary.
2. Heavy Metals
    The current specifications for lakes for food use (Sec. 82.5) 
establish limits of 10 ppm lead, 1.4 ppm arsenic, and ``not more than 
trace'' levels of total heavy metals (other than lead and arsenic). In 
the 1979 NOI, the agency proposed adding a specification for mercury in 
lakes. The agency tentatively finds that the manufacturing processes 
for lakes use metal salts that are sources of potential contamination 
by heavy metals; moreover, in its certification of lakes, the agency 
has rejected batches because of the presence of heavy metals, including 
lead. Therefore, the agency tentatively concludes that specifications 
to limit the levels of lead, arsenic, and mercury in lakes are 
necessary to ensure their safe use in food. As a result of its safety 
reviews of the straight colors used in food, the agency established 
limits of not more than 10 parts per million 

[[Page 8384]]
(ppm) lead, 3 ppm arsenic, and 1 ppm mercury in the specifications for 
most color additives permanently listed for food use in parts 73 and 
74. The agency tentatively concludes that such specifications are also 
sufficient to ensure the safety of lakes.
    FDA is unaware of any heavy metals, other than lead, arsenic, and 
mercury, that have a significant level of toxicity and that would be 
expected to occur in lakes. Therefore, the agency tentatively concludes 
that a general heavy metal specification is unnecessary to ensure the 
safety of lakes for food use.
    One comment received in response to the 1979 NOI suggested that a 
limitation on iron be included in the specifications for lakes for food 
use. Iron salts may be present in lakes as contaminants inadvertently 
introduced during the manufacturing process. For example, a batch of 
lake prepared using rusted equipment or water with a high iron content 
may contain iron salts.
    The agency has evaluated the safety of iron salts as a contaminant 
in lakes to determine whether their presence would present a sufficient 
safety hazard to warrant inclusion of a specification for iron. The 
agency notes that iron is an essential mineral, and that iron and many 
of its salts are affirmed as GRAS in part 184 for use as nutrients in 
food (for example, elemental iron, Sec. 184.1375; ferric ammonium 
citrate, Sec. 184.1296; ferric chloride, Sec. 184.1297; ferric sulfate, 
Sec. 184.1307; ferrous carbonate, Sec. 184.1307b; ferrous sulfate, 
Sec. 184.1315). However, the agency also notes that high levels of iron 
consumption can be toxic, especially for certain subpopulations. (See, 
e.g., 59 FR 51030, October 6, 1994).
    Lakes are generally used at low levels (typically less than 0.05 
percent) in foods, except for some low-consumption food items such as 
candy and candy coatings, colored sugar and frostings, dietary 
supplements, seasonings, flavorings, and chewing gum (Ref. 25). 
Therefore, consumption of iron due to its presence in lakes as a 
contaminant would be low. Under these circumstances, the agency finds 
no evidence of a safety hazard from exposure to iron as a contaminant 
in lakes for food use. Therefore, the agency tentatively concludes that 
a specification to limit the level of iron is unnecessary to ensure the 
safety of lakes for food use. Moreover, the agency notes that the 
conditions and practices that lead to the presence of iron salts as a 
contaminant in a batch of lake are addressed by the proposed 
requirement that lakes be prepared in accordance with CGMP (see section 
IV.B.5. of this document).
3. Soluble Chlorides and Sulfates
    Current Sec. 82.51 contains a specification that limits the content 
of the soluble chloride and sulfate anions in lakes for food use. The 
agency finds that the washing of the lake during the manufacturing 
process removes most of these water-soluble anions. Furthermore, as 
discussed above in section IV.A.3.c. of this document, the agency found 
in safety reviews conducted as part of several GRAS rulemakings that 
soluble chloride and sulfate anions are safe in foods at levels 
considerably greater than those found in lakes (Ref. 13). Therefore, 
the agency tentatively concludes that a specification to limit the 
levels of soluble chlorides and sulfates is unnecessary to ensure the 
safety of lakes prepared in conformity with CGMP for food use.
4. Inorganic Material Insoluble in HCl
    Current Sec. 82.51 contains specifications that limit the content 
of inorganic material insoluble in HCl in lakes. This specification was 
intended to ensure that the lake was prepared in accordance with CGMP 
and that no foreign material was inadvertently added during the laking 
process. However, agency certification records for lakes for food use 
in the past 20 years show that only one batch of lake has been denied 
certification based on this specification. Even without the 
specification for inorganic material insoluble in HCl, this batch of 
lake would not have met the requirements in this proposal because the 
alumina used as a substratum would not have met the applicable quality 
requirements. Furthermore, the agency is proposing to include in the 
specifications for lakes a provision to require that lakes be prepared 
in accordance with CGMP. Therefore, the agency tentatively concludes 
that a specification for material insoluble in HCl is unnecessary for 
lakes that meet the other proposed requirements for lakes, and such a 
specification is not included in this proposal.
5. Other Impurities and Contaminants
    The agency has tentatively concluded above that specifications to 
limit the level of total heavy metals (except lead, arsenic, and 
mercury), soluble chlorides and sulfates, and material insoluble in HCl 
are unnecessary to ensure the safety of lakes for food use as long as a 
general provision is included in the specifications for lakes to ensure 
that they are prepared in conformity with CGMP. The identity 
requirements and specifications in color additive regulations include 
impurities that are expected to occur at significant levels in a color 
additive that has been prepared in accordance with CGMP. In its 
certification of color additives, FDA has occasionally denied 
certification for batches of color additives due to the presence of 
significant levels of impurities for which the listing regulation 
contains no specifications. In a few instances, these impurities could 
be linked to improper storage of the color additive or to cross-
contamination from insufficiently cleaned processing equipment. In most 
cases, the source of the impurity was unknown. Based on the agency's 
experience in certifying thousands of batches of color additives 
annually, corroborated by the agency's analyses of reference standards 
(reference batches of color additives) used in toxicological studies of 
various straight colors as part of the safety reviews of these color 
additives, FDA believes that the impurities in the rejected batches 
would not have been present had the color additives been manufactured 
under conditions consistent with CGMP.
    As noted above in section IV.A.1.c. of this document, it is 
important that lakes be prepared in accordance with CGMP to ensure that 
the straight color does not degrade during preparation of the lake. 
Manufacturing conditions must be controlled so that levels of uncolored 
components in the straight color, including the carcinogenic 
constituents in certain monoazo and pyrazolone straight colors, do not 
increase during preparation or handling of the lake. CGMP includes use 
of proper temperatures, especially during drying, to avoid affecting 
the composition of the lake, and sufficient washing of the lake to 
remove water-soluble impurities. For example, the agency recently 
rejected a batch of a monoazo straight color because the batch exceeded 
the specifications for certain carcinogenic constituents. Subsequent 
discussions with the manufacturer revealed that the batch had been 
previously certified, but had failed to meet the manufacturer's 
microbiological specifications and had been reprocessed (redried). 
After redrying, the batch no longer met the specification for trace-
level carcinogenic constituents. The agency notes, however, that 
because of their chemical properties, such carcinogenic constituents 
are unlikely to be incorporated into lakes to the same extent as into 
straight colors, and sufficient washing of the lake could significantly 
decrease the levels of these constituents.
    To ensure the safety of lakes for use in foods, FDA is proposing to 
continue 

[[Page 8385]]
the requirement in existing Sec. 82.5 that lakes shall be free from 
impurities other than those named in the specifications, to the extent 
that such impurities may be avoided by CGMP. However, the agency is not 
proposing to define specific conditions that would constitute CGMP in 
the preparation of lakes. The agency recognizes that appropriate 
manufacturing conditions may differ for the preparation of different 
lakes and, in fact, may change over time. Furthermore, even the 
preparation of a single lake that meets the requirements of part 74 may 
be accomplished using different conditions of manufacture. The agency 
wants to retain the current flexibility in preparation of lakes for 
food use, but maintain the assurance that there will be no significant 
degradation of the straight color during preparation of the lake and 
that the resulting lake will be otherwise in compliance with the 
requirements of part 74. To accomplish this objective, the agency is 
not proposing to define any specific conditions of CGMP; however, in 
its review of notices claiming certification for batches of lake, the 
agency is proposing to use the accountability of the straight color in 
the lake, calculated as described below, as an indicator of the use of 
CGMP in the preparation of the lake.
    Under the current certification procedure for FD&C lakes, the 
agency can monitor both the use of certified batches of straight color 
in lakes for food use and indicators for the use of CGMP in the 
preparation or repack of a batch of lake. In a request for 
certification for a batch of lake, the firm must declare the certified 
lot number and the poundage from that lot for the straight color that 
is added to prepare the lake. The agency can determine a poundage 
accountability of the batches of straight colors that are used to 
prepare FD&C lakes. This accountability ensures that no more straight 
color is used in FD&C lakes than has been certified. For example, a 
firm that owns a 100-pound batch of straight color cannot credibly 
claim to use 1,000 pounds from that batch to make lakes.
    From the information in the request for certification and from 
analysis of the sample submitted with the request, the agency 
determines the total color accountability for each batch of lake (the 
amount of total color that was added to the batch of lake compared to 
the total color of the resulting batch). This accountability for total 
color is an indicator for the use of CGMP in the preparation or repack 
of a batch of lake. In its determination of accountability of the 
straight color in lakes for food use, the agency calculates a 
theoretical range for the expected total color content of a lake based 
on the minimum total color permitted in the listing regulation for the 
straight color, the maximum total color possible for the straight color 
(100 percent), the weight of straight color used to prepare the lake, 
and the weight of the lake. For example, for a 100-pound batch of FD&C 
Yellow No. 5 aluminum lake on alumina that was prepared from 25 pounds 
of FD&C Yellow No. 5, the theoretical range for the expected total 
color content of the lake would be from 21.8 percent to 25 percent. 
This theoretical range allows for variations in total color resulting 
from factors that normally occur during the manufacture of a lake, such 
as incomplete laking of the color and bleeding of the color during 
washing.
    The agency is requesting comments on the usefulness of total color 
accountability as an indicator of the use of CGMP in the preparation 
and repacking of batches of lake.

C. Certification Requirement

    The agency has evaluated the necessity, in the interest of public 
health, for the certification of lakes prepared from certified batches 
of straight color. The agency tentatively concludes that continued 
batch certification of lakes is necessary to protect the public health. 
The agency bases this tentative conclusion on two safety issues: The 
need to ensure the safety of the components (straight colors, 
precipitants, and substrata) used to prepare a lake; and the need to 
ensure that lakes are prepared and repacked under conditions of CGMP to 
prevent degradation of the straight color.
    The agency's traditional means for postmarket assurance of product 
safety is the collection and analysis of a sample. However, as 
discussed in section IV.A.1.b. of this document, suitable analytical 
methodology is not available to identify and quantify all potentially 
harmful impurities that may be present in lakes. Therefore, the agency 
tentatively concludes that the premarket controls afforded by the 
certification requirement are necessary to allow FDA to verify that the 
conditions for safe use of lakes are being met. Therefore, the agency 
is proposing to list lakes in part 74 as color additives subject to 
certification.
    Certification will allow the agency to confirm, before a lake is 
marketed, that only safe and suitable components have been used to 
prepare it; that any batches of straight color used in the lake were 
previously certified; and that the straight-color component of the lake 
has not degraded during manufacture or repacking. The agency 
tentatively concludes, however, that not all aspects of the current 
batch certification procedure are necessary to accomplish these 
objectives, and is proposing a simplified procedure for certifying 
batches of lakes. This proposed procedure is discussed in section VI.B. 
of this document.
    The agency is specifically requesting, as comments on this 
proposal, comments on the usefulness of its proposed certification 
procedure for the intended purpose of protecting the public health.

D. Provisions of Proposed Sec. 74.50 Lakes for Use in Foods

    The agency is proposing new Sec. 74.50 to list lakes permanently 
for use in foods as color additives subject to certification. Section 
74.50(a)(1), (a)(2), and (a)(3) would designate the components 
permitted for use in lakes for coloring food. These paragraphs would 
authorize the use of certified batches of one or more of the straight 
colors FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Yellow 
No. 5, FD&C Yellow No. 6, and FD&C Red No. 40; the substratum alumina 
that either conforms to the requirements for alumina under 
Sec. 73.1010(a)(1) and (b), or is a suspension in water of precipitated 
aluminum hydroxide prepared from aluminum sulfate that meets the 
requirements of the Food Chemicals Codex 2d ed. (1972) and sodium 
carbonate or sodium hydroxide that meets the requirements of the Food 
Chemicals Codex 3d ed. (1981); and precipitants that form the aluminum 
cation (Al+3) and the anion chloride (Cl-1) or sulfate 
(SO4-2).
    Proposed Sec. 74.50(a)(4) would provide that only diluents that are 
permitted in mixtures of straight colors for food use may be used in 
color additive mixtures containing lakes for such use.
    Proposed Sec. 74.50(b) would prescribe the following specifications 
for lakes for food use: Lead (not more than 10 ppm), arsenic (not more 
than 3 ppm), mercury (not more than 1 ppm). It would also state that 
lakes shall be free from impurities other than those named in the 
specifications, to the extent that such impurities may be avoided by 
CGMP.
    Proposed Sec. 74.50(c)(1) would permit the use of lakes in foods 
generally, except in foods subject to a standard of identity that does 
not authorize such use. The proviso relating to standardized foods 
would clarify that authorization for use of lakes in this regulation 
does not take precedence over any restrictions on color additive use in 
a food standard regulation. 

[[Page 8386]]
Currently, all the straight colors authorized for use in lakes for food 
use are approved for the same food uses. Because this may not always be 
the case, however, proposed Sec. 74.50(c)(2) would restrict the use of 
a lake manufactured from more than one straight color to those uses 
common to all of the straight colors in the lake.
    Proposed Sec. 74.50(d) would identify each lake made as prescribed 
in Sec. 74.50(a) as a listed color and would prescribe the formation of 
its listed name from the names of the certified straight colors present 
in the lake (in descending order of predominance), followed by the name 
of the cation of the precipitant (aluminum) and followed by the words 
``lake on alumina.'' The anion component of the precipitant would not 
be included in the name of the lake because this anion is removed 
during processing under conditions of CGMP and is not a component of 
the final lake.
    Proposed Sec. 74.50(e)(1) would require that the label of the lake 
and of any mixtures prepared from it for coloring purposes conform to 
the requirements of Sec. 70.25. Proposed Sec. 74.50(e)(2) would require 
that the label of food products that contain a lake declare the 
presence of the lake in accordance with Sec. 101.22(k) (21 CFR 
101.22(k)). Proposed Sec. 74.50(e)(3) would require that butter, 
cheese, and ice cream that contain a lake of FD&C Yellow No. 5 or FD&C 
Yellow No. 6 be labeled in accordance with Sec. 101.22(k)(1). These 
proposed labeling provisions are discussed more fully in sections 
VI.C.2. and VI.C.3. of this document.
    Proposed Sec. 74.50(f) would require that all batches of lakes be 
certified in accordance with proposed regulations in part 80.

V. Safety Review and Proposed Actions for Lakes for Use in Drugs and 
Cosmetics

A. Review of Components of Lakes for Use in Drugs and Cosmetics

    The current provisional listing regulations for lakes for use in 
drugs and cosmetics generally (Sec. 82.1051) and for use in external 
drugs and cosmetics only (Sec. 82.2051) provide for use of the 
following components: (1) The straight colors FD&C Blue No. 1 
(Sec. 82.101), FD&C Blue No. 2 (Sec. 82.102), FD&C Green No. 3 
(Sec. 82.203), FD&C Yellow No. 5 (Sec. 82.705), FD&C Yellow No. 6 
(Sec. 82.706), D&C Blue No. 4 (Sec. 82.1104), D&C Green No. 5 
(Sec. 82.1205), D&C Green No. 6 (Sec. 82.1206), D&C Orange No. 4 
(Sec. 82.1254), D&C Orange No. 5 (Sec. 82.1255), D&C Orange No. 10 
(Sec. 82.1260), D&C Orange No. 11 (Sec. 82.1261), FD&C Red No. 4 
(Sec. 82.304), D&C Red No. 6 (Sec. 82.1306), D&C Red No. 7 
(Sec. 82.1307), D&C Red No. 17 (Sec. 82.1317), D&C Red No. 21 
(Sec. 82.1321), D&C Red No. 22 (Sec. 82.1322), D&C Red No. 27 
(Sec. 82.1327), D&C Red No. 28 (Sec. 82.1328), D&C Red No. 30 
(Sec. 82.1330), D&C Red No. 31 (Sec. 82.1331), D&C Red No. 33 
(Sec. 82.1333), D&C Red No. 34 (Sec. 82.1334), D&C Red No. 36 
(Sec. 82.1336), D&C Violet No. 2 (Sec. 82.1602), D&C Yellow No. 7 
(Sec. 82.1707), D&C Yellow No. 8 (Sec. 82.1708), D&C Yellow No. 10 
(Sec. 82.1710), and Ext. D&C Yellow No. 7 (Sec. 82.2707a); (2) the 
substrata alumina, blanc fixe, gloss white, clay, titanium dioxide, 
zinc oxide, talc, rosin, aluminum benzoate, and calcium carbonate; (3) 
precipitants containing the cations sodium (Na+1), potassium 
(K+1), aluminum (Al+3), barium (Ba+2), calcium 
(Ca+2), strontium (Sr+2), and zirconium (Zr+4). 
Additionally, the lakes of FD&C Red No. 40 prepared with the substrata 
and precipitants listed above are permanently listed in Secs. 74.1340 
and 74.2340.
    The identity and specifications for the straight colors used to 
prepare lakes are provided in the regulations cited above and generally 
cross-reference the requirements of the permanent listing for the 
straight color in part 74. As to substrata, Sec. 82.3 defines three of 
the substrata used in lakes (alumina, blanc fixe, gloss white), but 
provides no specifications for the materials to be used. Part 82 does 
not identify or prescribe specifications for other substrata (clay, 
titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, and 
calcium carbonate) for lakes for drug or cosmetic use, or for the 
precipitants to be used in the preparation of these lakes.
1. Straight Colors
    a. Identity and uses. As discussed in sections III.C.1. and 
III.C.6.a. of this document, the agency has tentatively concluded that 
several of the straight colors currently listed for use in lakes for 
coloring drugs and cosmetics either do not form lakes (D&C Red No. 17, 
D&C Red No. 30, D&C Red No. 36, D&C Violet No. 2, and D&C Green No. 6) 
or were not present in any batch of lake certified for drug or cosmetic 
use before the enactment of the 1960 amendments (D&C Orange No. 11, D&C 
Yellow No. 7, D&C Yellow No. 8, and D&C Green No. 5). The proposed 
termination of the provisional listing of these straight colors for use 
in lakes would mean that lakes of these straight colors would no longer 
be permitted for coloring drugs and cosmetics. (See Table 1 in section 
III.C. of this document for a summary of the current and proposed 
regulatory status of straight colors addressed in this rulemaking.)
    The agency has already reviewed the identity and safety of the 
remaining straight colors currently permitted as components of lakes 
for coloring drugs and cosmetics, either as part of its scientific 
review of provisionally listed straight colors or in response to 
petitions for the review of new color additives (Sec. 71.1). On the 
basis of these reviews, the agency concluded that these straight colors 
are safe for use in drugs and cosmetics and issued regulations in part 
74 permanently listing them for such uses. The agency is proposing to 
continue to permit the use of these straight colors as components of 
lakes for use in drugs and cosmetics, subject to the exceptions and 
proposed requirements discussed below.
    In the Federal Register of September 30, 1975 (40 FR 44812), the 
agency restricted the provisional listing of FD&C Blue No. 2 to uses in 
foods and ingested drugs, the uses for which a petition had been filed 
for the permanent listing of the color additive. In the Federal 
Register of February 4, 1983 (48 FR 5252), the agency published a final 
rule permanently listing FD&C Blue No. 2 for use in food (Sec. 74.102) 
and ingested drugs (Sec. 74.1102). However, the provisional listing for 
the lake of FD&C Blue No. 2 (Sec. 82.102) was not amended accordingly. 
Therefore, despite the lack of a listing in part 74 authorizing the use 
of FD&C Blue No. 2 in cosmetics, the provisional listing regulations 
still permit the use of lakes of FD&C Blue No. 2 in cosmetics. Proposed 
Sec. 74.2050 would correct this inconsistency by excluding FD&C Blue 
No. 2 from the straight colors permitted as components of lakes for 
cosmetic use.
    The lakes of D&C Red No. 34 are provisionally listed in part 82 for 
use in drugs and cosmetics without any restrictions. However, the 
straight color is listed in part 74 for external drug and external 
cosmetic uses only (Secs. 74.1334 and 74.2334), based on the agency's 
safety evaluation of the straight color. The proposed permanent 
listings for lakes for drug and cosmetic use (Secs. 74.1050 and 
74.2050) would correct this inconsistency by limiting the use of a lake 
to the use(s) permitted for the straight-color component(s) of the 
lake. Thus, under the proposed regulations, any lake containing D&C Red 
No. 34 would be allowed for use only in externally applied drugs and 
externally applied cosmetics.
    b. Use of previously certified batches. Currently, under 
Secs. 82.1051 and 82.2051, manufacturers may use uncertified batches of 
straight colors to 

[[Page 8387]]
prepare most lakes for drug and cosmetic use. The resulting lake is 
then subject to batch certification. The exceptions are the lakes of 
D&C Red No. 33 (Sec. 82.1333), D&C Red No. 36 (Sec. 82.1336), and FD&C 
Yellow No. 6 (Sec. 82.706), which must be prepared from previously 
certified batches of the straight color. (As discussed in section 
III.C.1. of this document, the agency is proposing to terminate the 
listing of D&C Red No. 36 as a straight-color component of a lake for 
drug or cosmetic use because it does not contain a salt-forming group.)
    For the reasons discussed in section IV.A.1.b. of this document, 
the agency tentatively concludes that the lack of adequate analytical 
methods to determine levels of intermediates and other impurities in 
lakes prepared from uncertified batches of straight colors precludes 
the agency from prescribing conditions of safe use for lakes prepared 
from uncertified batches of straight colors. Accordingly, the agency is 
proposing to require that lakes for use in drugs and cosmetics, 
including externally applied drugs and cosmetics, be prepared from 
certified batches of straight colors.
    As discussed above, under current regulations the lakes of many D&C 
straight colors are prepared from uncertified batches of the straight 
colors. However, lakes of D&C Red Nos. 6, 7, 31, and 34 are commonly 
produced in situ (a process described in section I. of this document). 
In FY-95 (Ref. 18), lakes of these straight colors represented about 55 
percent of the total quantity of D&C lakes certified. The agency 
recognizes that its proposal to require the use of certified batches of 
straight color to prepare lakes for coloring drugs and cosmetics would, 
in effect, prohibit use of the in situ process for preparing lakes. 
However, as noted above, the reason for this proposed requirement is 
that the safety of lakes prepared from uncertified batches of straight 
color (including lakes prepared in situ) has not been demonstrated. 
Specifically, the agency is not aware of the existence of any methods 
that may be used to demonstrate that lakes produced by the in situ 
process meet the specifications for impurities, including carcinogenic 
constituents (e.g., para-toluidine in D&C Red Nos. 6 and 7), in the 
listing regulation for the straight color. Because FDA has the 
responsibility to ensure that color additives in foods, drugs, and 
cosmetics are safe for their intended uses, the fact that no methods 
that allow the safety of lakes produced in situ to be demonstrated 
appear to be available leads the agency to propose that use of the in 
situ method be discontinued. FDA recognizes, however, that the 
potential costs associated with this proposed action may be 
considerable, and therefore solicits proven methodology for analysis of 
the lake for the impurities specified in the listing regulation for the 
straight color. If such information is received in response to this 
proposal, the need to prohibit the use of lakes prepared by the in situ 
process will be obviated.
    c. Stability. The straight colors that FDA proposes to permit as 
components of lakes for drug or cosmetic use fall into the following 
eight groups, based on chemical structure (Refs. 16 and 17): 
Triphenylmethane (FD&C Blue No. 1, FD&C Green No. 3, D&C Blue No. 4); 
pyrazolone (FD&C Yellow No. 5); monoazo (FD&C Red No. 4, FD&C Red No. 
40, FD&C Yellow No. 6, D&C Orange No. 4, D&C Red No. 6, D&C Red No. 7, 
D&C Red No. 31, D&C Red No. 33, and D&C Red No. 34); indigoid (FD&C 
Blue No. 2); fluoran (D&C Orange No. 5, D&C Orange No. 10, D&C Red No. 
21, and D&C Red No. 27); xanthene (D&C Red No. 22 and FD&C Red No. 28); 
quinoline (D&C Yellow No. 10), and nitro (Ext. D&C Yellow No. 7). In 
FY-95, D&C lakes accounted for approximately 20 percent of the total 
poundage of lakes certified (Ref. 18). Of the D&C lakes certified in 
FY-95, approximately 55 percent were lakes of the monoazo dyes 
(primarily lakes of D&C Red Nos. 6 and 7), about 20 percent were lakes 
of the fluoran and xanthene dyes (primarily lakes of D&C Red Nos. 21 
and 27), and about 15 percent were lakes of quinoline dye (D&C Yellow 
No. 10). No batches of lakes of the nitro dye (Ext. D&C Yellow No. 7) 
were certified in FY-95.
    Section IV.A.1.c. of this document sets forth the agency's 
evaluation of data confirming the stability of certain straight colors 
in the triphenylmethane, pyrazolone, monoazo and indigoid classes 
during the laking process. This information includes data received from 
CTFA in response to the 1979 NOI (Ref. 19), data generated by FDA (Ref. 
21), and published studies (Refs. 17 and 22). In addition to these 
data, the agency received a preliminary stability study for two 
additional lakes prepared from monoazo dyes (FD&C Red No. 4 and D&C 
Orange No. 4) (Ref. 26). The study, which was conducted by a color 
additive manufacturer, compared the levels of total color, uncombined 
intermediates, and subsidiary color in a certified batch of each 
straight color to the levels of these materials in an aluminum lake 
prepared from the batch. The study found no evidence that the straight 
color degraded during manufacture of the lake.
    Based on its evaluation of all these data, the agency tentatively 
concludes that when prepared in accordance with CGMP,straight colors in 
the monoazo, triphenylmethane, pyrazolone, and indigoid classes do not 
degrade significantly during preparation of lakes for use in drugs or 
cosmetics.
    The agency received no studies evaluating the stability of the 
straight colors in the fluoran, xanthene, quinoline, or nitro groups 
during the laking process. However, the agency has reviewed 
certification records for batches of lakes made from straight colors in 
the fluoran, xanthene (Ref. 27), and quinoline (Ref. 28) classes. The 
agency has not certified a batch of lake of Ext. D&C Yellow No. 7 since 
1975; therefore, no recent certification data are available for lakes 
of Ext. D&C Yellow No. 7.
    The lakes of straight colors in the fluoran, xanthene, and 
quinoline groups are not required to be prepared from certified batches 
of straight color. Nevertheless, for lakes of the quinoline dye, D&C 
Yellow No. 10, the agency determined that one manufacturer used 
certified lots of D&C Yellow No. 10 to prepare the lake. The agency 
evaluated certification reports for the 36 such batches of D&C Yellow 
No. 10 lake that were certified in FY-95. The agency compared the 
levels, adjusted for total color content of the lake, of one 
intermediate (24 batches) and one subsidiary color (36 batches) in the 
batches certified to the levels permitted for these impurities in the 
straight color. The agency also determined total color accountability 
for all 36 batches. As discussed in section IV.B.5. of this document, 
the total color accountability was determined by comparing the actual 
total color content of each batch of lake with the range of estimated 
total color content for the same batch. The actual total color content 
of the batch of lake was determined during certification of the batch. 
The range of expected total color content of the lake was determined 
from the amount (weight) of straight color in the batch, multiplied by 
the range of expected total color content of the batch of straight 
color (as a percentage), and divided by the weight of the batch of 
lake. The lower limit of the range of expected total color content of 
the straight color was the minimum total color permitted by the 
applicable specification in the listing regulation for the straight 
color. The upper limit of the range was assumed to be 100 percent.
    All but one of the batches contained levels of the intermediate and 
subsidiary color that, adjusted for total color content of the lake, 
were within the limit set by the specification for the 

[[Page 8388]]
straight color. These data show that it is technologically feasible to 
prepare lakes of D&C Yellow No. 10 from certified batches of straight 
color without significant increases in impurities derived from the 
straight color. Over 40 percent of the batches had a total color 
content within the theoretical range of expected color content. The 
data showed that, after an adjustment for the total color content of 
the lake, the levels of sulfonated quinaldines, which are presumptive 
products of decomposition, remained within the specification limit for 
the straight color. Therefore, the agency tentatively finds that the 
data are adequate to conclude that there is no significant degradation 
of D&C Yellow No. 10 during laking under conditions of CGMP.
    The agency also evaluated FY-95 certification reports for lakes of 
the fluoran and xanthene straight colors. These lakes were all prepared 
from uncertified batches of straight color. To make its evaluation as 
accurate as possible, the agency compared levels (adjusted for total 
color content of the lake) of impurities found in the lakes to the 
maximum levels permitted for the same impurities in certified batches 
of straight color. The agency combined the data from the fluoran and 
xanthene classes of lakes because, during the laking process, the 
lactone group in the xanthene dyes is converted to the corresponding 
salt. Therefore, lakes of straight colors from the xanthene class are 
structurally identical to the lakes of comparable straight colors from 
the fluoran class.
    The agency evaluated the certification reports from the 104 batches 
of lakes of the fluoran and xanthene straight colors that had been 
certified in FY-95, including 16 reports for lakes of the xanthene 
straight colors D&C Red No. 22 (3 batches) and D&C Red No. 28 (13 
batches) and 88 reports for lakes of the fluoran straight colors D&C 
Orange No. 5 (4 batches), D&C Red No. 21 (23 batches), and D&C Red No. 
27 (61 batches). The agency compared the levels (adjusted for total 
color content of the lake) of three intermediates (55 batches) and one 
subsidiary color (104 batches) in these batches to the levels of these 
impurities permitted by the specifications in the listing regulation 
for the straight color. The agency also determined the total color 
accountability for 104 batches. (The theoretical range of expected 
total color content for these batches of lakes was determined in the 
same manner as described above for batches of D&C Yellow No. 10 lakes.) 
All but four of the batches contained levels of the intermediates and 
subsidiary color that, after adjusting for the total color content of 
the batch, met the specifications for the straight color. These data 
show that it is technologically feasible to prepare lakes of the 
fluoran and xanthene straight colors without significant degradation of 
the straight color. Over 60 percent of the batches had a total color 
content that was within the theoretical range of expected color 
content. The analyses showed that, after adjustment for the total color 
content of the lake, levels of the subsidiary colors 
tribromofluoresceins (D&C Red Nos. 21 and 22) and the lower halogenated 
fluoresceins (D&C Red Nos. 27 and 28), which are prime indicators of 
possible dehalogenation (a decomposition reaction) of the parent 
compound, remained within the applicable specifications for the 
straight color. Therefore, the agency tentatively finds that the data 
are adequate to conclude that no significant degradation of these 
straight colors occurs during preparation of lakes under conditions 
consistent with CGMP.
    The agency tentatively concludes that the available information 
provides sufficient evidence for the stability of the straight-color 
component of lakes prepared from colors in the monoazo, pyrazolone, 
triphenylmethane, indigoid, fluoran, xanthene, and quinoline classes. 
Although the agency has not evaluated data for all of the straight 
colors that FDA is proposing to approve as components of lakes for drug 
and cosmetic use, the agency tentatively concludes that the available 
information is adequate to conclude that there is no significant 
degradation of straight colors in these classes during the preparation 
of lakes in accordance with CGMP.
    The agency has no data on the stability of the nitro straight 
color, Ext. D&C Yellow No. 7, during the laking process. No lakes of 
this straight color were certified in FY-95; the last batch of this 
lake was certified by the agency in 1975. Based on the absence of data 
concerning the stability of Ext. D&C Yellow No. 7 during the laking 
process, the agency tentatively concludes that it has insufficient data 
to ensure the safety of lakes prepared with Ext. D&C Yellow No. 7. 
Therefore, the agency is not proposing to permit the use of Ext. D&C 
Yellow No. 7 as a component of lakes for drug or cosmetic use. 
Consequently, the proposed termination of the provisional listings of 
lakes (see section VI.A.2. of this document) would remove the listing 
for lakes of Ext. D&C Yellow No. 7. Anyone interested in the permanent 
listing of lakes of Ext. D&C Yellow No. 7 should submit, as a comment 
on this proposal, data showing the stability of Ext. D&C Yellow No. 7 
during the laking process. If data on the stability of Ext. D&C Yellow 
No. 7 lakes are received as a comment on this proposal, the agency will 
consider permanently listing the lakes of Ext. D&C Yellow No. 7 in the 
final rule.
    The agency has also considered the safety evaluations for the 
straight colors discussed above. Based on these safety evaluations and 
the data showing the stability of straight colors when the laking 
process is conducted in accordance with CGMP, the agency tentatively 
concludes that, when lakes are prepared under conditions of CGMP, the 
certified batches of straight colors listed in proposed Secs. 74.1051 
and 74.2051 are safe for use in lakes for the same drug and cosmetic 
uses as part 74 allows for the straight colors. Therefore, the agency 
is proposing to permit certified batches of these straight colors as 
components of lakes for drug or cosmetic use.
    As discussed in section IV.A.1.c. of this document, the agency is 
not proposing to establish a definition of CGMP for the preparation of 
lakes. Rather, FDA is proposing to permit any manufacturing method that 
ensures that straight colors do not significantly degrade during 
laking.
    d. Use of more than one straight color in a lake. For the reasons 
discussed in section IV.A.1.d. of this document, the agency is also 
proposing to permit the preparation of a lake from certified batches of 
more than one straight color.
2. Substrata
    a. Regulatory approach. The agency is proposing to include the 
following in its permanent listing regulations for lakes for drug and 
cosmetic use as substrata permitted for preparing such lakes: alumina, 
barium sulfate, kaolin, titanium dioxide, zinc oxide, talc, aluminum 
benzoate, calcium carbonate, and rosin. In addition, gloss white will 
also be permitted, although not explicitly listed in the regulations, 
because FDA is proposing to allow combinations of substrata. Thus, all 
of the substrata currently permitted as components of lakes for drug 
and cosmetic use under Secs. 82.1051 and 82.2051, the provisional 
listing regulations, will continue to be permitted under the proposed 
regulations.
    Ordinarily, the agency establishes identity and specification 
requirements for the color additive, rather than for the components 
used to make the color additive. However, because of the unique 
characteristics of lakes, the agency is proposing to regulate them 
under a broadly based, flexible system that permits the use, in drug 
and 

[[Page 8389]]
cosmetic products, of lakes that may contain a variety of components at 
varying levels. As noted above in section V.A.1.b. of this document, 
the agency is proposing to establish quality requirements (identity and 
specifications) for the straight-color components of lakes by requiring 
the use of certified batches of straight colors to prepare lakes. To 
ensure the safety of lakes prepared with the substrata listed above, 
and at the same time to permit manufacturers the continued flexibility 
to prepare lakes using any one or mixtures of these substrata at 
varying levels, the agency is proposing to establish quality 
requirements (identity and specifications) for these substrata or their 
components. In this way, the agency can ensure the safety of substrata 
used to prepare lakes without setting rigid specifications for the 
finished lake to limit impurities in substrata, which may be present at 
varying levels in a lake, and without requiring analysis of the lake 
itself for these impurities.
    b. Alumina. In section IV.A.2. of this document, the agency 
reviewed the identity and safety of alumina, and tentatively concluded 
that alumina is safe as a substratum in lakes for food use. 
Furthermore, alumina is listed in Sec. 73.1010 as a color additive for 
use in drugs generally at levels consistent with CGMP. Based on its 
review of the use of alumina as a substratum in lakes for food use and 
on the listing of alumina as a color additive safe for general use in 
drugs, the agency tentatively concludes that alumina is also safe for 
use as a substratum in lakes for drug and cosmetic use, provided that 
it either conforms to the identity and specification requirements in 
Sec. 73.1010 (a)(1) and (b), or is a suspension in water of 
precipitated aluminum hydroxide prepared from aluminum sulfate and 
sodium carbonate or sodium hydroxide that meet the requirements of Food 
Chemicals Codex 2d ed. (1972) (aluminum sulfate) or Food Chemicals 
Codex 3d ed. (1981) (sodium carbonate and sodium hydroxide).
    c. Barium sulfate (blanc fixe). Section 82.3(h) defines blanc fixe 
as ``a suspension in water of precipitated barium sulfate.'' The 
definition provides no quality requirements for blanc fixe as a 
substratum. This definition covers both preformed barium sulfate that 
is subsequently suspended in water and barium sulfate that is prepared 
in situ, without subsequent recovery and drying.
    The United States Pharmacopeia 23d ed. (1990) (USP) defines barium 
sulfate as ``BaSO4 233.39; sulfuric acid, barium salt (1:1); 
Barium sulfate (1:1) [7727-43-7]'' and provides specifications. The act 
recognizes the USP as an official drug compendium whose specifications 
are applicable to drug uses of substances listed therein (21 U.S.C. 
321(g)(1)(a) and 351(b)). Although the USP specifications for barium 
sulfate and other compounds discussed below that are recognized by the 
USP are not directly applicable for purposes of this proposal, the 
agency tentatively concludes that the USP specifications for these 
compounds when used as drugs are also appropriate for these compounds 
when they are used as substrata for lakes to color drugs.
    The agency has approved barium sulfate for use in adhesives 
(Sec. 175.105) and as a colorant for food-contact use (Secs. 178.3297 
(21 CFR 178.3297) and 176.170(b)(2)). As part of the current 
rulemaking, the agency also evaluated data relating to the safety of 
ingested and dermal uses of barium sulfate, and found no reports in the 
scientific literature of adverse effects resulting from topical use of 
barium sulfate. Moreover, scientific data establish that barium sulfate 
is highly insoluble. For example, the CRC Handbook of Chemistry and 
Physics (59th ed., 1978) reports that precipitated blanc fixe 
(BaSO4) has a solubility in water of 0.246 milligram (mg)/100 gram 
(g) at 26  deg.C and 0.4113 mg/100g at 100  deg.C and 60 mg/100g in 3 
percent HCl. Consequently, its absorption and toxicity are low. 
However, to provide further assurance of safety, the agency is 
proposing to retain the current specification for soluble barium of not 
more than 0.05 percent in lakes that contain a barium salt 
(Sec. 82.5(b)(3)). The agency tentatively concludes that barium sulfate 
that meets the requirements of the USP is safe for use as a substratum 
in lakes for drug and cosmetic use (Ref. 13).
    The definition in Sec. 82.3(h) for blanc fixe and the definition in 
Sec. 82.3(i) for gloss white (a suspension in water of co-precipitated 
aluminum hydroxide and barium sulfate) suggest that barium sulfate may 
be prepared in situ either alone or with alumina during the manufacture 
of lakes. The International Pharmacopoeia 3d ed. (1979) describes the 
preparation of barium sulfate suspension by mixing barium chloride 
solution, sulfate-free ethanol, and potassium sulfate solution. The 
WHO's Specifications for Reagents Mentioned in the International 
Pharmacopoeia (1963) describes barium chloride and potassium sulfate 
and provides specifications for each. However, the agency has no 
information to confirm that the International Pharmacopeia method and 
the identity and specifications for barium chloride in the WHO 
publication represent CGMP for preparing barium sulfate in situ as 
substrata for lakes for drug or cosmetic use. Therefore, the agency 
requests comments on appropriate methodology for the in situ 
preparation of barium sulfate as a substratum, and on identity 
requirements and specifications for reagents used to prepare this 
substratum. If such comments are received and the information provided 
is satisfactory, the agency will list barium sulfate prepared in situ 
as a substratum in lakes for use in drugs and cosmetics.
    The agency is also proposing to substitute the name ``barium 
sulfate'' for ``blanc fixe.'' CTFA's comment on the 1979 NOI suggested 
this change in terminology. The agency notes that, in the past, the 
name ``blanc fixe'' was typically used to identify the substratum 
composed of barium sulfate in requests for certification of lakes. 
However, more recently, the name typically used for this substratum in 
requests for certification is ``barium sulfate.'' Therefore, the agency 
agrees with CTFA's comment and is proposing to substitute the name 
``barium sulfate'' for the name ``blanc fixe.''
    d. Gloss white. Section 82.3(i) defines gloss white as ``a 
suspension in water of co-precipitated aluminum hydroxide and barium 
sulfate''. As discussed above, the agency is proposing to permit both 
alumina and barium sulfate as substrata in lakes for drug or cosmetic 
use.
    Therefore, the agency is proposing not to list gloss white as a 
substratum in lakes for drug and cosmetic use, because the proposed 
regulations provide for combinations of substrata.
    e. Kaolin (clay). In the 1979 NOI, the agency stated that the term 
``clay'' does not adequately identify the chemical structure of this 
material. The NOI requested comments identifying the material and 
suggesting specifications to ensure its safe use as a substratum in 
lakes. CTFA's comment, submitted in response to the 1979 NOI, 
identified kaolin as the substratum material used in lakes.
    The USP (23d ed., 1995) defines kaolin as ``a native hydrated 
aluminum silicate, powdered and freed from gritty particles by 
elutriation,'' and provides specifications. The agency has affirmed 
clay (kaolin) as GRAS in Sec. 186.1256 as an indirect food ingredient. 
Section 186.1256 identifies clay (kaolin) as hydrated aluminum silicate 
(Al2O3.2SiO2.nH2O) and provides a CAS Registry 
number of 1332-58-7.
    The agency has reviewed data relating to the safety of ingested and 
dermal uses of kaolin and bentonite (a related 

[[Page 8390]]
mineral containing magnesium aluminum silicate). These data included 
data developed for the GRAS review of these compounds and data in a 
color additive master file, which included dermal toxicity data. The 
agency also considered a 90-day feeding study on magnesium aluminum 
silicate.
    Based on its review, the agency finds that kaolin is inert when 
applied externally and is not absorbed by the gastrointestinal tract. A 
search of the scientific literature revealed no reports of adverse 
effects resulting from topical use of kaolin. Therefore, the agency 
tentatively concludes that kaolin that meets USP specifications is safe 
for use as a substratum in lakes for drug and cosmetic use (Ref. 13).
    f. Titanium dioxide. The color additive regulation for titanium 
dioxide (Sec. 73.575) identifies titanium dioxide as ``synthetically 
prepared TiO2'' and provides specifications. Titanium dioxide is 
listed as a color additive exempt from certification for use in food 
(Sec. 73.575), in drugs generally (Sec. 73.1575), in cosmetics 
generally (Sec. 73.2575), and in certain medical devices 
(Sec. 73.3126). The USP (23d ed., 1995) recognizes titanium dioxide, 
defines it as ``TiO2 79.88; Titanium oxide (TiO2); Titanium 
oxide (TiO2) [13463-67-7],'' and provides specifications.
    The agency has evaluated the available data relating to the safety 
of ingested and dermal uses of titanium dioxide, including data 
supporting its use as a color additive, and more recent genetic and 
chronic toxicity studies in rats and mice. Based on these data, the 
agency tentatively concludes that titanium dioxide that meets the 
requirements of Sec. 73.575 (a)(1) and (b) is safe for use as a 
substratum in lakes for drug and cosmetic use (Ref. 13).
    g. Zinc oxide. The color additive regulation for zinc oxide 
(Sec. 73.1991) identifies zinc oxide as ``a white or yellow-white 
amorphous powder manufactured by the French process (described as the 
indirect process whereby zinc metal isolated from the zinc-containing 
ore is vaporized and then oxidized).'' Section 73.1991(b) provides 
specifications for zinc oxide. The USP (23d ed., 1995) recognizes zinc 
oxide, defines it as ``ZnO 81.39; Zinc oxide; Zinc Oxide [1314-13-2],'' 
and provides specifications.
    Zinc oxide is listed as a color additive exempt from certification 
for use in externally applied drugs (Sec. 73.1991) and in cosmetics 
generally (Sec. 73.2991). Zinc oxide is also GRAS for use as a dietary 
supplement (Sec. 182.5991) and as a nutrient (Sec. 182.8991).
    The agency has evaluated data relating to the safety of ingested 
and dermal uses of zinc oxide, including a safety review of zinc 
compounds as food ingredients by the Select Committee on GRAS 
Substances of the Federation of American Societies for Experimental 
Biology and the data supporting the safety of zinc oxide as a color 
additive. Based on these data, the agency tentatively concludes that 
zinc oxide that meets the requirements of Sec. 73.1991 (a)(1) and (b) 
is safe for use as a substratum in lakes for drug and cosmetic use 
(Ref. 13).
    h. Talc. The color additive regulation for talc (Sec. 73.1550) 
identifies talc as ``a finely powdered, native, hydrous magnesium 
silicate sometimes containing a small proportion of aluminum silicate'' 
and provides specifications. Talc is a color additive exempt from 
certification for use in coloring drugs generally (Sec. 73.1550) and is 
GRAS for certain indirect food uses (Secs. 182.70 and 182.90). The USP 
(23d ed., 1995) defines talc as ``a native, hydrous magnesium silicate, 
sometimes containing a small proportion of aluminum silicate,'' and 
provides specifications.
    The agency has evaluated the available data relating to the safety 
of ingested and dermal uses of talc, including a safety review of 
silicates (including talc) as food ingredients by the Select Committee 
on GRAS Substances of the Federation of American Societies for 
Experimental Biology and the data supporting the safety of talc as a 
color additive. Based on these data, the agency tentatively concludes 
that talc that meets the requirements of Sec. 73.1550 (a)(1) and (b) is 
safe for use as a substratum in lakes for drug and cosmetic use (Ref. 
13).
    i. Aluminum benzoate. During the preparation of a lake with 
aluminum benzoate as a substratum, aluminum benzoate is produced in 
situ using benzoic acid and the aluminum cation. The Merck Index (11th 
ed., 1989) identifies aluminum benzoate as C21H15AlO6 or 
Al(C6H5COO)3 with a molecular weight of 390.30. The USP 
(23d ed., 1995) recognizes aluminum chloride, aluminum sulfate, and 
benzoic acid (the components used to prepare aluminum benzoate). The 
USP (23d ed., 1995) defines benzoic acid as ``C7H6O2 
122.12; Benzoic acid; Benzoic acid [65-85-0]'' and provides 
specifications. The U.S.P. (23d ed., 1995) defines aluminum chloride as 
``AlCl3 6H2O; Aluminum chloride, hexahydrate; Aluminum 
chloride hexahydrate [7784-13-6]; Anhydrous 133.34 [7446-70-0]'' and 
provides specifications. The USP (23d ed., 1995) defines aluminum 
sulfate as ``Al2(SO4)3 xH2O (anhydrous) 342.16; 
Sulfuric acid, aluminum salt (3:2), hydrate; Aluminum sulfate (2:3) 
hydrate [17927-65-0]; Anhydrous 342.16 [10043-01- 3]'' and provides 
specifications.
    The agency has affirmed benzoic acid (Sec. 184.1021) and sodium 
benzoate (Sec. 184.1733) as GRAS for use in food as flavoring agents 
and adjuvants and as antimicrobial agents. In addition, the standard of 
identity for margarine (21 CFR 166.110) permits the use of the sodium, 
potassium, and calcium salts of benzoic acid as preservatives. The 
agency has also reviewed safety data on the ingested and dermal uses of 
benzoic acid and benzoates, including a safety review of benzoic acid 
and benzoates as food ingredients by the Select Committee on GRAS 
Substances of the Federation of American Societies for Experimental 
Biology and information identified in a search of the scientific 
literature published from 1981 to 1987 on benzoic acid and benzoates. 
The agency's review found no reports of adverse toxicological effects 
of ingested or topically administered benzoic acid.
    The agency's evaluation of the safety of aluminum salts, including 
aluminum chloride and aluminum sulfate, is discussed in section IV.A.2. 
of this document under the safety of alumina as a substratum in lakes 
for food use.
    Based on these data, the agency tentatively concludes that aluminum 
benzoate prepared from benzoic acid and aluminum chloride or aluminum 
sulfate that meet the USP specifications for these compounds is safe 
for use as a substratum in lakes for drug and cosmetic use (Ref. 13).
    j. Calcium carbonate. The color additive regulation for calcium 
carbonate (Sec. 73.1070) identifies calcium carbonate as ``a fine, 
white, synthetically prepared powder consisting essentially of 
precipitated calcium carbonate (CaCO3).'' Calcium carbonate is 
listed as a color additive exempt from certification for use in drugs 
generally (Sec. 73.1070). Calcium carbonate has also been affirmed as 
GRAS for general food use (Sec. 184.1191) and is GRAS for dietary 
supplement use (Sec. 182.5191).
    The agency has evaluated the available data relating to the safety 
of ingested and dermal uses of calcium salts, including calcium 
carbonate. These data, including a safety review of calcium salts as 
food ingredients by the Select Committee on GRAS Substances of the 
Federation of American Societies for Experimental Biology and data 
supporting the safety of calcium carbonate as a color additive, 
establish that calcium is ubiquitous in nature and 

[[Page 8391]]
that its salts are commonly found in food. Based on its review, the 
agency tentatively concludes that calcium carbonate that meets the 
requirements of Sec. 73.1070 (a)(1) and (b) is safe for use as a 
substratum in lakes for drug and cosmetic use (Ref. 13).
    k. Rosin. ``Rosin'' is a generic term encompassing a variety of 
substances that may vary considerably in their composition. For 
example, the Merck Index (11th ed., 1989) defines rosin as ``Residue 
left after distilling off the volatile oil from the oleoresin obtained 
from'' various species of Pinus. Gum rosin is obtained from the 
oleoresin of living pine trees and wood rosin is extracted from the 
wood of the stumps of pine trees. Another type of rosin is tall oil 
rosin, a by-product of the wood pulp industry. The CRC Handbook of 
Chemical Synonyms and Trade Names (8th ed., 1978) also lists rosin 
under its synonym 'colophony' and defines it as ``The residue which 
remains after the volatile oils have been removed by the distillation 
of crude turpentine.'' The CRC Handbook lists several varieties of 
rosins obtained from different species of pine.
    Rosin is approved as a food additive for use as a natural flavoring 
substance for alcoholic beverages (Sec. 172.510). Various rosins and 
rosin derivatives are approved for other food additive uses: In 
coatings of fresh citrus fruits (Sec. 172.210) and as plasticizing 
materials or softeners in chewing gum base (Sec. 172.615). Rosin and 
rosin derivatives are approved as diluents in color additive mixtures 
for use in inks for marking food supplements in tablet form, gum, 
confectionery, fruit, and vegetables (Sec. 73.1(b)) and, by reference, 
in inks for branding pharmaceutical forms (Sec. 73.1001(a)(2)). 
Numerous rosins and rosin derivatives are approved as indirect food 
additives (substances that are not added to food directly but that may 
become part of food through migration from materials in contact with 
the food) (Sec. 178.3870).
    The agency has evaluated the available data relating to the safety 
of rosin and related compounds, including data supporting the food 
additive and color additive diluent uses of rosin and rosin 
derivatives, and data obtained by the agency from searches of the 
scientific literature in 1988 and 1994 for information concerning 
rosin. The agency's literature searches did not find any reports of 
adverse toxicological effects from ingested rosin. However, many 
publications reported cases of allergic contact dermatitis and 
occupational asthma resulting from exposure to certain rosin materials 
(Ref. 13).
    In the 1979 NOI, the agency requested information on the chemical 
composition of rosin and suggestions for specifications to ensure its 
safe use in lakes for drug and cosmetic use. CTFA's comment on the 1979 
NOI provided general information on rosin, but did not identify the 
specific types of rosin that are used as substrata in lakes. However, 
the monograph for rosin in the CTFA International Cosmetic Ingredient 
Dictionary, 5th ed., 1993 defines rosin as ``the residue left after 
distilling off the volatile oil from the oleoresin obtained from Pinus 
palustris and other species of Pinaceae (Ref. 29). Because this 
definition clearly identifies gum rosin, and not wood rosin or tall oil 
rosin, the agency tentatively concludes that the rosin used in cosmetic 
products is gum rosin.
    Based on its review of available data (Refs. 29 and 30), the agency 
has tentatively identified the rosin used as a substratum in lakes for 
drug and cosmetic use as gum rosin, and is proposing to define and set 
specifications for rosin based on this tentative conclusion. It is 
unclear, however, whether all lake manufacturers who use rosin as a 
substratum are using gum rosin. Therefore, any manufacturer who uses 
rosin other than gum rosin that meets the requirements in the proposed 
regulation as a substratum in lakes for drug or cosmetic use should 
submit information about the identity and specifications of such rosin 
as a comment on this proposal. The comment should include the 
manufacturer's product specifications and any analytical data that 
establish the identity and purity of the rosin. The agency will 
consider modifying the identity and specifications for rosin if it 
receives information to substantiate the safe use of rosin other than 
gum rosin.
    In response to the concerns raised by the agency about the topical 
safety of rosin lakes, the CTFA submitted reports of numerous human 
sensitization and photosensitization studies on cosmetic products 
colored with rosinated lakes of D&C Red No. 6, D&C Red No. 7, and D&C 
Red No. 34. The studies involved a total of 2,381 subjects for 
sensitization and 312 subjects for photosensitization; products tested 
included lipsticks, lip liner, blush, rouge, and nail polish. No skin 
sensitization/photoallergic reactions were reported in any of the test 
subjects. The agency tentatively concludes that these studies show that 
there is little risk of developing a skin sensitization reaction from 
skin contact with various cosmetic products that contain rosinated 
color additive lakes at levels found in such products, and, therefore, 
that use of rosin as a substratum in color additive lakes for external 
drug and cosmetic use is safe (Ref. 14).
3. Precipitants
    a. Aluminum (Al+3), barium (Ba+2), and calcium 
(Ca+2) cations. The safety of salts of the cations aluminum, 
barium, and calcium is discussed in the safety evaluations of alumina 
(sections IV.A.2. and V.A.2.b. of this document), barium sulfate (blanc 
fixe) (section V.A.2.c. of this document), and calcium carbonate 
(section V.A.2.j. of this document). Based on those evaluations, the 
agency tentatively concludes that these cations are safe as components 
of precipitants used in the preparation of lakes for drug and cosmetic 
use (Ref. 13). However, as stated in the discussion of the safety of 
barium sulfate as a substratum (section V.A.2.c.), the agency is 
proposing to retain the current specification for soluble barium (0.05 
percent) in lakes for drug or cosmetic use.
    b. Zirconium cation (Zr+4). Zirconium is a rare earth metal 
that closely resembles aluminum in pharmacological and chemical 
properties. The agency has evaluated data relating to the safety of 
ingested and dermal uses of zirconium salts. These data, including a 
review of published literature on the toxicity, physiological effects, 
and medicinal uses of zirconium and its salts, revealed nothing to 
indicate any likelihood of harm from topical administration or 
ingestion of low levels of zirconium salts (Ref. 13). Therefore, the 
agency tentatively concludes that zirconium is safe as a component of 
precipitants used in lakes for drug and cosmetic use.
    c. Sodium (Na+) and potassium (K+) cations. The salts of 
the sodium and potassium cations, sodium chloride and potassium 
chloride, are ubiquitous in nature. Sodium chloride (table salt) is 
GRAS (Sec. 182.1(a)) and potassium chloride has been affirmed as GRAS 
for food use (Sec. 184.1622). Most of the permanently listed water-
soluble straight colors subject to certification, including all the 
straight colors used as components of lakes under Sec. 82.51, are 
sodium salts. By virtue of their GRAS status, sodium chloride and 
potassium chloride are permitted under Sec. 73.1(a)(1) for use as 
diluents in color additive mixtures for coloring food, and under 
Sec. 73.1001(a)(1) and (b) are also permitted for use as diluents in 
color additive mixtures for coloring ingested drugs and externally 
applied drugs. Therefore, the agency tentatively concludes that these 
salts are safe for 

[[Page 8392]]
use as components of precipitants in lakes for drug or cosmetic use.
    d. Strontium cation (Sr+2). Strontium is an alkaline earth 
element and is a metabolic analog of calcium. The agency has evaluated 
published data on the safety of strontium cation. Because strontium can 
substitute for calcium, it can influence certain physiological 
parameters; however, the concentrations required to adversely affect 
these parameters are significantly higher than the levels encountered 
when strontium is used as a precipitant in a lake. Based on its review 
of the published data, the agency tentatively concludes that the use of 
strontium cation is safe as a component of precipitants used in lakes 
for drug and cosmetic use (Ref. 13).
    e. Accompanying anions. In section IV.A.3.c. of this document, the 
agency considered the safety of soluble chlorides and sulfates as 
components of precipitants in lakes for food use. As discussed more 
fully in that section, chloride and sulfate anions are found in many 
GRAS ingredients. In the safety reviews conducted as part of the GRAS 
rulemakings for these ingredients, the agency found that ingestion of 
chlorides and sulfates (in the presence of the accompanying cation) was 
safe at levels that vastly exceed the possible level of exposure to 
these anions as components of lakes. Therefore, the agency tentatively 
concludes that the presence of these anions in lakes prepared for food 
use is safe (Ref. 13). Furthermore, by virtue of their GRAS status, the 
salts of chloride and sulfate are permitted under Sec. 73.1(a)(1) for 
use as diluents in color additive mixtures for coloring food, and under 
Sec. 73.1001 (a)(1) and (b) are also permitted for use as diluents in 
color additive mixtures for coloring ingested drugs and externally 
applied drugs. Therefore, the agency tentatively concludes that these 
anions are safe for use as components of precipitants in lakes for drug 
or cosmetic use.
    f. Tentative conclusions. The agency tentatively concludes that the 
water-soluble chloride and sulfate salts of aluminum, barium, calcium, 
zirconium, sodium, potassium, and strontium are safe for use as 
components of precipitants in the preparation of lakes for drug or 
cosmetic use. The agency notes that, although these substances are 
discussed as distinct chemical compounds, the proposal would permit 
their use in other forms to prepare lakes, provided that no substance 
or ion that is not provided for in the regulation is introduced. For 
example, the proposal would allow the use of a precipitant formed in 
situ from the combination of a listed cation (as the hydroxide) and 
either hydrochloric or sulfuric acid.
4. Diluents in Color Additive Mixtures Containing Lakes
    The agency is not proposing any limitations on the diluents 
permitted in color additive mixtures for cosmetic use that are made 
with lakes. The part 74 listings for the straight colors that are 
components of lakes for cosmetic use do not limit the use of diluents 
in mixtures for coloring cosmetics. Moreover, no regulation in part 73 
specifies safe diluents for cosmetic use. However, the agency notes 
that cosmetic products containing color additive mixtures are subject 
to the adulteration provisions of section 601 of the act.

B. Specifications for Lakes for Use in Drugs and Cosmetics

1. Intermediates and Other Impurities Derived from Straight Colors
    The provisional listing regulations for lakes for drug or cosmetic 
use (Secs. 82.1051 and 82.2051) contain specifications for ether 
extracts (not more than 0.5 percent) and intermediates (not more than 
0.2 percent) in such lakes. The agency established these specifications 
to limit the levels of intermediates and other impurities in lakes 
prepared from uncertified batches of straight colors. However, as 
discussed in section IV.A.1.b. of this document, proven methodology to 
analyze all lakes for intermediates and other impurities is not 
available. Therefore, the agency is proposing to require the use of 
certified batches of straight colors to ensure safe levels of 
intermediates and other impurities in lakes. In light of this proposed 
requirement, the agency tentatively concludes that specifications for 
ether extracts, intermediates, and subsidiary colors in lakes for drug 
or cosmetic use are unnecessary to ensure the safety of such lakes.
2. Precipitants
    Because lakes are washed when prepared in accordance with CGMP, the 
agency anticipates that only low levels of water-soluble contaminants 
from these precipitants will remain in the finished lake. Furthermore, 
the proposed specifications for the lake would limit the levels of 
contaminants of toxicological concern (primarily heavy metals) 
permitted in the end product. However, the agency tentatively concluded 
in its discussion of barium sulfate as a substratum (section V.A.2.c. 
of this document) and barium as a precipitant (section V.A.3.a. of this 
document) that a specification to limit soluble barium in lakes for 
drug or cosmetic use should be retained to provide an extra margin of 
safety. Based on these considerations, the agency tentatively concludes 
that specifications for residues from precipitants used in lakes for 
drug or cosmetic use, except for soluble barium, are unnecessary.
3. Heavy Metals
    As discussed in section IV.B.2. of this document, the manufacturing 
processes for lakes involve reagents that are sources of potential 
contamination by metals. Currently, lakes are subject to the following 
general specifications in Sec. 82.5 for provisionally listed colors for 
drug or cosmetic use: 20 ppm lead, 2 ppm arsenic, 0.003 percent total 
heavy metals (except for lead and arsenic), and, for those colors that 
contain a barium salt, a limit of 0.05 percent on soluble barium. As 
discussed in section IV.B.2. of this document, FDA is proposing limits 
for lead, arsenic, and mercury in lakes for food use. The agency 
tentatively concludes that specifications to limit the levels of lead, 
arsenic, mercury, and soluble barium are also necessary to ensure safe 
use of lakes in drugs and cosmetics. The agency is unaware of any other 
heavy metals that have a significant level of toxicity and that would 
be expected to occur in lakes. Therefore, the agency tentatively 
concludes that a general heavy metal specification is unnecessary to 
ensure the safety of lakes for drug or cosmetic use.
    The agency is proposing to maintain the specifications of not more 
than 20 ppm lead and 0.05 percent soluble barium for lakes for drug or 
cosmetic use and to raise the arsenic specification from not more than 
2 ppm to not more than 3 ppm. The agency is also proposing to include a 
mercury specification of not more than 1 ppm. The proposed levels for 
arsenic and mercury are the levels that the agency tentatively 
concludes are necessary to ensure the safety of color additives used in 
drugs and cosmetics, based on safety evaluations in rulemakings for the 
permanent listing of numerous straight colors.
4. Soluble Chlorides and Sulfates
    Current Secs. 82.1051 and 82.2051 contain a specification that 
limits the content of the soluble chloride and sulfate anions in lakes 
for drug and cosmetic use. As noted in section IV.B.3. of this 
document, most of the water-soluble chloride and sulfate anions are 
washed out during preparation of the lake under CGMP conditions. In its 
safety review, the agency found that these anions are safe in foods, 
drugs, and cosmetics at levels considerably greater than those found in 
lakes (Ref. 13). Therefore, the agency 

[[Page 8393]]
tentatively concludes that a specification to limit the levels of 
soluble chlorides and sulfates is unnecessary to ensure the safety of 
lakes prepared in conformity with CGMP for drug or cosmetic use.
5. Other Residues
    The 1979 NOI requested information on certain other chemicals 
occasionally used in the laking process, such as citrate, acetate, and 
surfactants. CTFA's comment did not provide a list of such substances, 
but stated that the substances used were GRAS. A comment from a color 
manufacturer identified specific substances that the company uses in 
the manufacture of lakes and characterized them as food additives or 
GRAS substances. The company stated that the surfactants were used at 
very low concentrations and that the nature of the use prevented any 
significant amount from being present in the final lake.
    The agency recognizes that it is impracticable to set 
specifications for every chemical used in the manufacture of a color 
additive. The agency generally sets specifications to limit the 
substances that are normally expected to be present in the final 
additive, especially those substances that could present a safety 
hazard at foreseeable levels of exposure. The agency agrees with the 
comment that the surfactants and other chemicals mentioned are used at 
low concentrations. The agency further agrees that, because of the 
washing of lakes during manufacture, these chemicals are unlikely to be 
present at significant levels in a lake that has been prepared under 
conditions of CGMP and that is otherwise in compliance with applicable 
regulations. Therefore, the agency is not proposing specifications for 
residues of these substances in lakes for drug and cosmetic use.
6. Other Impurities and Contaminants
    The agency has tentatively concluded above that specifications to 
limit the levels of total heavy metals (except lead, arsenic, mercury, 
and soluble barium), soluble chlorides and sulfates, and residues of 
other chemicals are unnecessary to ensure the safety of lakes for drug 
and cosmetic use, as long as a general provision is included in the 
specifications for lakes to ensure that they are prepared in conformity 
with CGMP. Therefore, the agency is proposing to continue the 
requirement in existing Sec. 82.5 that lakes be free from all 
impurities other than those named in the specifications, to the extent 
that such impurities can be avoided by CGMP.

C. Certification Requirement

    As discussed in section IV.C. of this document, the agency has 
evaluated the necessity for the certification of lakes and has 
tentatively concluded that certification is necessary to protect the 
public health. The simplified procedure the agency is proposing for 
certification of lakes is described in section VI.B. of this document.

D. Provisions of Proposed Regulations

1. Proposed Section 74.1050 Lakes for Use in Drugs
    The agency is proposing a new Sec. 74.1050 to list lakes 
permanently for use in drugs as color additives subject to 
certification. Paragraphs (a)(1), (a)(2), and (a)(3) would designate 
the components permitted for use in preparing lakes for coloring drugs. 
These paragraphs would permit the use of one or more certified batches 
of one or more of the color additives FD&C Blue No. 1, FD&C Blue No. 2, 
FD&C Green No. 3, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 4, 
FD&C Red No. 40, D&C Blue No. 4, D&C Orange No. 4, D&C Orange No. 5, 
D&C Orange No. 10, D&C Red No. 6, D&C Red No. 7, D&C Red No. 21, D&C 
Red No. 22, D&C Red No. 27, D&C Red No. 28, D&C Red No. 31, D&C Red No. 
33, D&C Red No. 34, and D&C Yellow No. 10 (see Table 1); one or more of 
the substrata alumina, aluminum benzoate, barium sulfate, calcium 
carbonate, kaolin, rosin, talc, titanium dioxide, and zinc oxide; and 
one or more precipitants that form the cation aluminum (Al+3), 
barium (Ba+2), calcium (Ca+2), potassium (K+), sodium 
(Na+), strontium (Sr+2), or zirconium (Zr+4), and the 
anion chloride (Cl-) or sulfate (So4-2). Paragraph (a)(3) 
would require that the substrata (except alumina), or for aluminum 
benzoate, the components of the substrata, conform to the identity and 
purity requirements of the applicable color additive regulation or, if 
no such regulation exists, to the requirements of the USP 23d ed. 
(1995). The paragraph would require that alumina conform to the 
requirements of Sec. 74.50(a)(3).
    Proposed Sec. 74.1050(a)(4) would limit the diluents used in color 
additive mixtures containing lakes to those diluents that are suitable 
and that are listed in Sec. 73.1001 as diluents for drug use. This 
requirement is consistent with the existing requirements for mixtures 
of color additives for drug use and will ensure that color additive 
mixtures containing lakes are safe for drug use. As discussed in 
section III.C.2.b. of this document, the agency is proposing to amend 
Sec. 73.1001 to permit additional diluents in color additive mixtures 
for drug use.
    Proposed Sec. 74.1050(b) would prescribe the following 
specifications for lakes for drug use: lead (not more than 20 ppm); 
arsenic (not more than 3 ppm); mercury (not more than 1 ppm); soluble 
barium (not more than 0.05 percent). It would also state that such 
lakes shall be free from impurities other than those named in the 
specifications, to the extent that such impurities may be avoided by 
CGMP.
    Proposed Sec. 74.1050(c)(1) would restrict the use of a lake to 
uses common to all of the straight colors in the lake. For example, use 
of a lake of the straight colors FD&C Red No. 4 and FD&C Blue No. 1 
would be limited to externally applied drugs and cosmetics because of 
the limitations on the use of FD&C Red No. 4. Proposed 
Sec. 74.1050(c)(2) would also specify that where regulations for the 
straight color impose quantitative limitations for the use of such 
straight color in drug products, the amount of such straight color in a 
lake shall be considered as a part of the total amount of such straight 
color permitted in a drug product.
    Proposed Sec. 74.1050(d) would identify each lake made as 
prescribed in Sec. 74.1050(a) as a listed color and would prescribe the 
formation of its name from the names of the straight colors present in 
the lake (in descending order of predominance), followed by the names 
of the cations of the precipitants, and followed by the words ``Lake on 
______ and ______'' (inserting the listed names of the substrata in 
descending order of predominance). For example, the name of a lake 
prepared by the extension of FD&C Yellow No. 5, FD&C Yellow No. 6 and 
D&C Orange No. 5 on alumina using aluminum chloride as the precipitant 
would be ``FD&C Yellow No. 5, FD&C Yellow No. 6 and D&C Orange No. 5 
Aluminum Lake on Alumina''. The anion component of the precipitant 
would not be included in the name of the lake because this anion is 
removed during processing and is not a component of the finished lake.
     Proposed Sec. 74.1050(e)(1) would require that the label of the 
lake and of any mixtures prepared from it for coloring purposes conform 
to the requirements of Sec. 70.25 of this chapter. Proposed 
Sec. 74.1050(e)(2) would require that drug products that contain a lake 
of FD&C Yellow No. 5 comply with the label declaration requirements of 
Sec. 74.1705(c)(2) and (c)(3). Proposed Sec. 74.1050(e)(3) would 
require that drug products that contain a lake of FD&C Yellow No. 6 
comply with the label declaration requirements of proposed 
Sec. 74.1706(c)(2). These proposed labeling 

[[Page 8394]]
provisions are discussed more fully in sections VI.C.2. and VI.C.3. of 
this document.
    Proposed Sec. 74.1050(f) would require that all batches of lakes be 
certified in accordance with proposed regulations in part 80.
2. Proposed Sec. 74.2050 Lakes for Use in Cosmetics
    The agency is proposing new Sec. 74.2050 to list lakes permanently 
for use in cosmetics as color additives subject to certification. 
Proposed paragraph (a) would identify the components permitted for use 
in preparing lakes for coloring cosmetics by incorporating the identity 
provisions proposed in Sec. 74.1050(a)(1), (a)(2), and (a)(3) for lakes 
for use in drugs, except that FD&C Blue No. 2 would not be permitted as 
a straight-color component in lakes for cosmetic use. Proposed 
Sec. 74.2050(a) also would incorporate the specifications in proposed 
Sec. 74.1050(b).
    Proposed Sec. 74.2050(b) would prescribe the same uses and 
restrictions for lakes for cosmetic use as proposed for lakes for drug 
use in Sec. 74.1050(c).
    Proposed Sec. 74.2050(c) would identify each lake made as 
prescribed in Sec. 74.2050(a) as a listed color and would prescribe the 
formation of its name in the same manner as proposed in 
Sec. 74.1050(d).
    Proposed Sec. 74.2050(d)(1) would require that the label of the 
lake and of any mixtures prepared from it for coloring purposes conform 
to the requirements of Sec. 70.25. Proposed Sec. 74.2050(d)(2) would 
require the ingredient labeling of lakes in cosmetic products to comply 
with proposed Sec. 701.3(c)(1)(i). These proposed labeling provisions 
are discussed more fully in sections VI.C.2. and VI.C.3. of this 
document.
    Proposed Sec. 74.2050(e) would require that all batches of lakes be 
certified in accordance with proposed regulations in part 80.

VI. Other Proposed Actions

A. Removal of Provisional Listings

1. Removal of 21 CFR Part 81
    The agency is proposing to remove Part 81 General Specifications 
and General Restrictions for Provisional Color Additives for Use in 
Foods, Drugs, and Cosmetics. This part was originally issued in 1960 
(25 FR 9759, October 12, 1960) to provide for the listing of 
commercially established color additives permitted for provisional use 
under the transitional provisions of the 1960 amendments, and to 
establish conditions for the continued provisional listing of these 
color additives pending completion of studies required to establish 
their safety for permanent listing.
    Currently, only lakes are listed in Sec. 81.1 Provisional lists of 
color additives. The final rule based on this proposal will remove 
these entries. When the final rule becomes effective, the section will 
no longer be necessary. The remaining three sections, Sec. 81.10 
Termination of provisional listings of color additives; Sec. 81.30 
Cancellation of certificates; and Sec. 81.32 Limitations of 
certificates, concern past agency actions on provisionally listed color 
additives and are purely of historical interest, as the color additives 
referred to in these sections are no longer permitted for use in FDA-
regulated products. In addition, after FDA completes action on this 
proposal and the final rule terminating all provisional color additive 
listings becomes effective, no further additions to part 81 will be 
possible. Therefore, the agency is proposing to remove the entire part.
2. Removal of 21 CFR Part 82
    The agency is proposing to remove Part 82--Listing of Certified 
Provisionally Listed Colors and Specifications. The purpose of this 
part was to prescribe the identity, specifications, and uses of 
provisionally listed color additives. Currently, the regulations in 
this part apply only to lakes. When the final rule resulting from this 
proposal becomes effective, all remaining provisional listings in part 
82 will terminate. Therefore, the agency is proposing to remove the 
entire part.

B. Certification Procedure for Lakes

1. Overview
    The current requirements and procedures for batch certification of 
lakes are described in part 80. Under the provisions of Sec. 80.21, a 
firm that has prepared or repacked a batch of lake submits a request 
for certification of the batch to FDA. The request provides the name, 
batch number, and batch weight of the lake or repack; information on 
storage pending certification; and the uses for which certification is 
requested. For a newly manufactured batch of lake, the request also 
provides the name, quantity, and (where applicable) the lot number of 
the straight color used, the identity of the precipitant used, the 
identity and quantity of the substratum used, and the identity (name 
and address) of the manufacturer of the lake. For a repack of a 
certified batch of lake, the request provides the original lot number, 
certified color content, and name and address of the source from which 
the repacker obtained the lake. (See section III.A.7. of this document 
for the proposed definition of ``repack.'') The request must be 
accompanied by the required certification fee, which varies according 
to the type of request and weight of the batch (Sec. 80.10), and a 
representative sample from the batch accompanied by any label or 
labeling intended for use with the batch (Sec. 80.22).
    The agency evaluates the request and analyzes the sample to ensure 
that they meet the requirements of part 82, including identity, 
specifications, and uses of the lake. After evaluation of the 
information in the request and laboratory analysis of the sample, the 
agency determines whether the request meets the requirements for 
certification. For those requests that meet these requirements, the 
agency issues the requester a certificate (Sec. 80.31). The certificate 
states the name of the requester, the name of the color additive, the 
FDA certification lot number, the uses and restrictions that apply to 
the color additive, and the results of the agency's analyses of the 
batch. Upon receipt of the certificate, the requester then labels the 
batch with the certification lot number, the percent total color, uses 
and restrictions, and other labeling as required in Sec. 70.25. The 
requester is also required to maintain the batch, both before and after 
certification, under conditions that ensure that the composition of the 
batch does not change and that the sample submitted to FDA for 
certification remains representative of the batch until the batch has 
been packaged and labeled as required by Secs. 70.20 and 70.25 
(Secs. 80.37 and 80.38). The person to whom the certificate is issued 
is required to keep complete records showing the disposal of all color 
additive from the batch covered by the certificate until at least 2 
years after disposal of the batch (Sec. 80.39).
    The requirement for certification of lakes and repacks ensures that 
the agency can identify each firm that manufactures or repacks a lake. 
Under its inspectional authority, the agency can then inspect these 
establishments and determine compliance with labeling and storage 
requirements and verify the disposal of the batch. The regulations 
enable the agency to ensure the continued safety of lakes and other 
color additives after certification by establishing conditions 
(Sec. 80.32) under which a certificate will expire and the batch will 
be deemed to be uncertified. In addition, the agency can refuse 
certification service (Sec. 80.34) to firms that submit requests for 
certification but fail to comply with requirements designed to ensure 
the safety of certified 

[[Page 8395]]
color additives, including recordkeeping and allowing inspection of the 
firm's color additive inventory and records.
    This batch certification procedure provides the agency with an 
integrated system for ensuring the safety of lakes for use in foods, 
drugs, and cosmetics. For each batch of lake certified, the agency 
maintains, as records, the original request for certification and a 
copy of the certificate for the batch, which includes the results of 
agency analysis of the representative sample. The agency's analysis of 
the representative sample includes tests for total color, heavy metals, 
and impurities derived from the straight color used to prepare the 
lake.
    As discussed in section IV.C. of this document, the agency has 
tentatively concluded that many requirements of the current batch 
certification system are necessary to ensure that lakes are safe for 
use in foods, drugs, and cosmetics, and thus to protect the public 
health. However, the agency also tentatively concludes that FDA 
analysis of a representative sample of the batch is not necessary in 
light of the other requirements for lakes being proposed. Therefore, 
the agency is proposing to establish a simplified procedure in 
Sec. 80.31(b) for certification of batches of lakes and lake repacks. 
The agency notes that both new batches of lakes and repacks of 
previously certified batches of lakes would be subject to the new 
procedure. In subsequent discussion of the proposed certification 
requirements for lakes, the agency will address requirements for lakes 
generically and will distinguish between new batches and repacks only 
when it is necessary to identify specific requirements relating to only 
one type of batch. In the remainder of this document, the term ``batch 
of lake'' should be understood to encompass both new batches and 
repacks.
    Under the proposed procedure, certification of a batch of lake 
would rely on the certificates for the batches of straight colors that 
are used in the lake, either directly to prepare the lake or indirectly 
as components of a certified batch of lake that is blended into the new 
batch. The certification of the batch would also rely on 
representations by the manufacturer or repacker that the batch complies 
with the requirements of parts 74 and 80.
    The proposed procedure would require that a batch of lake meet the 
requirements of the proposed listing regulation for the lake in part 
74, that the manufacturer of the lake be the same firm that was issued 
the certificates for all batches of straight color in the batch of 
lake, and that the firm complete the requirements of proposed 
Sec. 80.33 for notifying the agency of the firm's claim to 
certification for the batch. The proposed procedure would also require 
that the firm submitting the notice maintain records of the composition 
and disposal of the batch, including the certificates for the straight 
colors used to make the batch. Repackers would be required to retain 
proof that the original batch of lake was certified, in lieu of the 
certificates for the batches of straight color used to prepare the 
lake. The manufacturer or repacker would also be required to retain a 
representative sample of the batch.
    This proposed procedure would provide for routine agency review of 
only the information necessary to ensure the use of certified batches 
of straight color and to verify that the straight color in the lake did 
not degrade significantly during the laking process. Under this 
proposed procedure, the agency would not routinely monitor compliance 
with the remaining requirements for the preparation and repacking of 
lakes under the regulations in part 74. However, as noted above, the 
certification of a batch of lake would be based both on the agency's 
review of the critical factors in lake manufacturing and repacking and 
on the manufacturer's and repacker's representations of compliance with 
the remaining requirements. The agency would be able to verify these 
representations by inspecting the manufacturer's or repacker's records, 
and violations of the requirements for certification would be addressed 
under proposed Secs. 80.32 and 80.34.
    Under the proposed procedure, a manufacturer or repacker of a batch 
of lake would submit to FDA a notice claiming certification for the 
batch and providing the information and fee specified in proposed 
Secs. 80.10(c) and 80.33. The notice would provide the same information 
about the batch that is currently provided in a request for 
certification under Sec. 80.21(j), or generated by the agency as part 
of its evaluation of the certification request. However, the person 
submitting the notice would not be required to submit a representative 
sample of the batch for analysis by the agency. The agency would review 
the notice and, if the information in the notice was complete and 
appeared to comply with the requirements of parts 74 and 80, would 
issue an acceptance of the notice. Upon FDA's issuance of its 
acceptance of the notice, the batch covered by the notice would be a 
certified batch.
    As noted above, the proposed certification procedure for batches of 
lakes and certified lake repacks would not require submission of a 
representative sample for agency analysis. Instead, the proposed new 
procedure would require that the manufacturer or repacker of the batch 
provide certain analyses and maintain certain records for agency 
inspection. Under the proposed procedure, the agency also would not 
issue a certificate for the batch. As noted above, the proposed 
certification procedure would rely on the certificates issued by the 
agency for the straight-color components of batches of lake and the 
representations of the manufacturer or repacker about the composition 
of the batch. Under this proposed procedure, certification of a batch 
of lake would be complete upon the agency's acceptance of the firm's 
notice claiming certification. This notice would provide information 
that would allow the agency to identify the certificates for the 
straight colors on which the certification of the lake relies and to 
ensure that the batch otherwise complies with the requirements of parts 
74 and 80.
    The agency is proposing to continue the application of the current 
storage and labeling requirements for batches pending certification and 
after certification (Secs. 80.37 and 80.38) to batches of lakes 
certified under the proposed new procedure.
    Amended Sec. 80.39 would continue the application of the current 
recordkeeping requirements for certified color additives to lakes, 
including repacks, and would add recordkeeping requirements for lakes 
only to support the information and affirmations contained in the 
firm's notice to FDA.
    Amended Sec. 80.32 would provide for conditions under which the 
certification of a batch of lake would expire, and would add a 
provision to allow a certified color additive, including a lake, to be 
used in a batch of lake without losing its certification.
    Amended Sec. 80.34 would continue the agency's authority to refuse 
certification service to manufacturers and repackers of lakes who 
falsify records, obtain certification by fraud, or otherwise abuse the 
certification system.
    The proposed certification procedure would provide a simplified 
system for assuring the safety of a certified batch of lake. For the 
reasons discussed in section VI.B.2.b. of this document, preparation of 
a lake would be limited to the firm issued the certificates for the 
straight colors used in the batch of lake. For each certified batch of 
lake, the agency would retain the original notice claiming 
certification for the batch and a copy of its response to the notice. 
The notice for each new certified batch of lake would contain the lot 
numbers for 

[[Page 8396]]
the batches of straight colors used to prepare the batch of lake. This 
information would allow the agency to ensure that the batch of lake 
meets the requirements in part 74. The proposed requirement for 
submission of a premarket notice claiming certification would ensure 
that the agency could identify every firm that prepares or repacks 
certified batches of lakes. Under its inspectional authority, the 
agency could then inspect these establishments and their records to 
ensure compliance with the composition requirements of part 74 and the 
certification requirements of part 80, including the recordkeeping 
requirements of amended Sec. 80.39. As part of a typical inspection, 
the agency might look at the facility, verify the records of the 
disposal of the batch, and check compliance with storage and labeling 
requirements.
    The current batch certification procedure for lakes does not 
provide for certification of mixtures containing lakes. Color additive 
mixtures containing lakes are exempted from certification under 
Sec. 80.35(b), subject to the conditions in that regulation. The agency 
is proposing to retain this exemption.
2. Certification Requirements
    a. Current provisions for batch certification. The current 
requirements for batch certification of color additives in Sec. 80.31 
include references to parts 81 and 82. As discussed in section VI.A. of 
this document, the agency is proposing to delete parts 81 and 82 in 
this rulemaking. Therefore, the agency is proposing to amend Sec. 80.31 
to delete all references to parts 81 and 82.
    Currently, Sec. 80.31(a)(2) requires that a certified color 
additive conform to specifications and other conditions in parts 81 and 
82. The section does not make any reference to specifications and other 
conditions in part 74, however. Because it appears that this omission 
was an oversight, the agency is proposing to amend Sec. 80.31(a)(2) to 
add a reference to part 74. This action will clarify that permanently 
listed straight colors are subject, as a condition of certification, to 
the specifications and other conditions in part 74 of this chapter.
    Currently, Sec. 80.31(b) specifies the conditions under which the 
agency shall refuse to certify a batch and the procedures for 
contesting such refusal. The agency is proposing to modify this 
paragraph to cover the proposed changes in the procedure for 
certification of lakes. The agency is also proposing to redesignate 
this paragraph as paragraph (c) to allow the addition of the proposed 
new procedure in new paragraph (b).
    b. Proposed certification provisions for lakes. The agency is 
proposing to add new Sec. 80.31(b) to specify the conditions under 
which a batch of lake or certified lake repack is a certified batch. 
Proposed Sec. 80.31(b) would require that a certified batch of lake or 
certified lake repack meet the specifications and any other conditions 
set forth in part 74 of this chapter. The agency tentatively concludes 
that this is an essential condition for certification because proposed 
Secs. 74.50, 74.1050, and 74.2050 specify the conditions under which 
lakes are safe for use in foods, drugs, and cosmetics.
    Proposed Sec. 80.31(b) would also require, as a condition of 
certification for a batch of lake, that the firm preparing the batch be 
the same firm that was issued the certificate for each batch of 
straight color used in the lake. The agency tentatively concludes that 
this provision is a necessary condition for certification because, 
under the proposed procedure, certification of a batch of lake relies 
on the certificates issued for the batches of straight colors that were 
used to prepare the lake.
    Under the proposed procedure, the agency would not issue a separate 
certificate for the batch of lake. Instead, the certificates for the 
straight colors in the lake would remain in effect provided that the 
lake was prepared in accordance with the regulations in part 74, 
including the requirement of preparation under conditions of CGMP such 
that the straight color does not significantly degrade. The agency 
recognizes that during the preparation of a lake, some change in the 
composition of the straight color inevitably occurs because the color 
goes from a water-soluble form in the straight color to a water-
insoluble form in the lake. However, it is the responsibility of the 
manufacturer of the lake to prevent avoidable changes in the 
composition of the straight color so that the certificates for all 
straight colors used in the lake remain valid. The agency tentatively 
concludes that the responsibility for assuring the validity of the 
certificates of the straight colors in a lake should be retained by the 
firm issued the certificates.
    The agency notes that a repacker of a certified lake would not be 
the same firm that was issued the certificates for the straight-color 
components of the lake. However, the handling of a lake during 
repacking is significantly less than during the preparation of the lake 
because no reprocessing occurs and no chemical reaction takes place; 
thus, the potential for change in composition is much less. 
Furthermore, a repack is derived from a single batch of lake, and the 
agency would keep on file all notices claiming certification for a 
batch of lake under Sec. 80.31(b) and all agency acceptances of such 
notices. Therefore, the agency would have the necessary information on 
the certification of the original batch of lake to compare to the 
information submitted in a notice claiming certification for a repack 
of the batch.
    Proposed Sec. 80.31(b) would require that a firm that prepares or 
repacks a batch of lake comply with the notification requirements of 
Sec. 80.33 as a condition of certification. Proposed Sec. 80.33 would 
require that the firm submit and obtain FDA acceptance of a notice 
claiming certification of the batch. The proposed notice would provide 
FDA with the same information, except for the representative sample of 
the batch, that is currently provided by the request for certification 
of a batch of lake or generated by the agency when it analyzes the 
sample and evaluates the request for certification.
    Proposed Sec. 80.31(b) would also require that a firm that prepares 
or repacks a batch of lake comply with the recordkeeping requirements 
of Sec. 80.39 as a condition of certification. Currently, Sec. 80.39 
requires that the person issued a certificate for a batch of color 
additive maintain records showing the disposal of all the color 
additive from the batch covered by the certificate. This section also 
specifies the types of records required to be kept and the required 
length of time for keeping the records, as well as requiring that such 
records be made available to agency representatives. This section 
further provides the agency access to check the correctness of the 
records. The agency is proposing to maintain the current recordkeeping 
requirements for lakes. The agency is also proposing to amend 
Sec. 80.39 to require additional records that would apply to lakes 
only. These additional records would allow the agency to verify the 
information provided in the notice claiming certification. The proposed 
new recordkeeping requirements are essential to the success of the 
simplified certification procedure for lakes, as they would provide the 
means for the agency to verify that a batch of lake has been prepared, 
repacked, and maintained in compliance with safety requirements, and to 
trace any batches that are found to have problems.
    The agency would review the notice claiming certification and, if 
the batch of lake covered by the notice appeared to comply with these 
requirements and the notice appeared to contain no 

[[Page 8397]]
untrue statement of a material fact, would issue an acceptance of the 
notice. Upon issuance of the acceptance, the batch covered by the 
notice, subject to the terms, conditions and restrictions prescribed in 
part 74, would be a certified batch.
3. Notification Requirements
    a. General requirements. An essential component of the agency's 
proposed certification procedure for lakes is the proposed requirement 
that a firm claiming certification for a batch of lake comply with the 
notification requirements in Sec. 80.33. The proposed notice would be 
the primary vehicle for providing the agency with the information 
needed to verify that the batch is safe for use in foods, drugs, and 
cosmetics.
    Proposed Sec. 80.33 (a), (b), (c), and (d) would require that a 
notice claiming certification for a batch of lake be addressed to the 
Commissioner of Food and Drugs, be prepared in the format specified in 
Sec. 80.33(i), be submitted in duplicate, and be signed by a 
responsible officer of the company (or, for a foreign manufacturer or 
repacker, by a responsible officer of the firm and by an agent of the 
firm who resides in the United States). Except for the format of the 
notice, these requirements are identical to the requirements for a 
request for certification of a batch of lake or repack under 
Sec. 80.21.
    Proposed Sec. 80.33(e) would require that a notice claiming 
certification for a batch of lake show the name and address of the firm 
submitting the notice. This information is needed to issue a response 
to the notice and also to identify the location of the batch and the 
records supporting the notice.
    Like existing Sec. 80.21(f), proposed Sec. 80.33(f) would require 
that the notice be accompanied by the fee prescribed in Sec. 80.10 
unless the firm has advanced a deposit to be used for prepayment of 
such fees. Currently, the fee for certification of lakes and lake 
repacks is based on the poundage of the color additive, with a minimum 
fee of $192.00 for a batch of lake and $30.00 for a repack. Under 
proposed Sec. 80.10(c), the fee for a notice claiming certification for 
a batch of lake or lake repack would be $30.00 regardless of the size 
of the batch. This proposed fee is based on the agency's estimate that 
reviewing and responding to a notice claiming certification would 
require approximately 1 hour. The agency estimates that average total 
personnel costs for these activities would be approximately $25.00 per 
notice with an additional $5.00 per notice for recordkeeping and other 
overhead costs. The agency is proposing a flat fee rather than a fee 
based on the poundage of lake certified because the manufacturer of a 
lake has already paid a fee based on poundage for the certification of 
the straight colors used in the lake. The agency estimates that the 
resources required for the administrative handling, review, and 
response to a notice claiming certification for a new batch of lake or 
a lake repack would be essentially the same. Therefore, the agency is 
proposing the same fee for both types of notices.
    Proposed Sec. 80.33(g) would require that a copy of the label or 
labeling intended to be used with the batch accompany the notice. This 
proposed requirement is comparable to the current requirement 
(Sec. 80.22(c)(5)) that the sample submitted with the request for 
certification be accompanied by a copy of the label or labeling 
intended to be used with the batch. The agency notes, however, that 
under proposed Sec. 80.33, no sample would be submitted with the 
notice.
    Proposed Sec. 80.33(h) would state that the name of the lake is 
derived as prescribed in part 74. This proposed provision is comparable 
to Sec. 80.21(h), which cross-references the regulations that prescribe 
the naming of straight colors, mixtures, and repacks.
    Under proposed Sec. 80.33(j), the agency would respond to the 
notice claiming certification for a batch of lake within 5 working days 
of receipt. The agency's response would either accept or reject the 
notice, as discussed in section VI.B.3.d. of this document.
    b. Requirements for new batches of lakes. Proposed Sec. 80.33(i)(1) 
would prescribe the format and content of a notice claiming 
certification for a newly prepared batch of lake. The notice would be 
required to contain the name of the lake, as prescribed in Secs. 74.50, 
74.1050, or 74.2050; the batch number (manufacturer's number); the 
weight of the batch; conditions of storage pending certification; and 
proposed uses. This information is comparable to that currently 
required for an application for certification of a lake under 
Sec. 80.21(j)(2).
    Proposed Sec. 80.33(i)(1) would also require that the notice state 
the total color content of the batch and the color content (as a 
percent of the batch) for each straight-color component of the lake. 
The total color content of a lake is essential to the identity of the 
lake, and necessary for the user of a lake to determine product 
formulation requirements and to ensure compliance with any quantitative 
limitations on the use of the straight-color component of a lake. 
Currently, in its routine certification analysis of the representative 
sample, the agency determines the total color content of a lake. This 
information is an essential part of the basis for the certificate 
issued by the agency. Under the proposed simplified certification 
procedure for lakes, the agency would not analyze a sample of the batch 
and determine the total color content. Rather, the manufacturer would 
provide this information in the notice, based on its analysis of the 
lake. These analyses would be part of the records that the manufacturer 
would be required to maintain for the batch of lake.
    Proposed Sec. 80.33(i)(1) would also require the notice to contain 
the following information for the components of the lake: the name, 
quantity used, and certification lot number of each batch of straight 
color used in the preparation of the lake; the name and quantity used 
of each precipitant or substratum ingredient in the lake, including the 
source of the chloride or sulfate anion; and, for each certified batch 
of lake blended into the batch, the name, quantity used, and 
certification lot number or FDA acceptance number (the number assigned 
to FDA's acceptance of the notice claiming certification). This 
information is comparable to that currently required for an application 
for certification of a lake under Sec. 80.21(j)(2). Although 
Sec. 80.21(j)(2) does not currently require information on certified 
batches of lakes that are blended into a new batch of lake, such 
information is important for describing the composition of a batch of 
lake and reflects a practice that is common in the industry. Such 
information is routinely included in current requests for certification 
of lakes under Sec. 80.21.
    In evaluating requests it has received for certification of batches 
of lakes, the agency has noted that, although the regulations for lakes 
in part 82 specify precipitants and substrata as distinct functional 
entities, the functions of ingredients that are added to the lake 
preparation for these purposes may overlap. Also, in some instances, 
acid is added to make a component water-soluble so that it can function 
as a precipitant in the laking process. Under proposed 
Sec. 80.33(i)(1), the required information on ingredients of the lake 
in the notice claiming certification would encompass all ingredients 
that are either identified in Secs. 74.50(a), 74.1050(a), or 74.2050(a) 
as components of lakes, or are added to form these components of lakes 
in situ. This information, together with the name of the lake, would 
provide the agency with the necessary information on the components of 
the lake and the ingredients used to form 

[[Page 8398]]
these components in the preparation of the lake.
    Proposed Sec. 80.33(i)(1) would also require statements affirming 
that the batch meets the requirements of 21 CFR parts 74 and 80; that 
the records required by Sec. 80.39, including a representative sample 
of the batch, are available for inspection by FDA; and that the firm 
submitting the notice is the manufacturer of the batch. These proposed 
affirmations are necessary to ensure that the batch of lake meets all 
the requirements of proposed Sec. 80.31(b) and, therefore, that the 
batch is safe for use in foods, drugs, or cosmetics.
    As discussed in section VI.B.1. of this document, the agency is 
proposing to provide for the certification of batches of lakes based on 
its review of the critical factors in lake manufacture and on the 
manufacturer's representations that the remaining requirements have 
been met. Under this proposed procedure, the agency would not routinely 
verify compliance with every requirement for the preparation and 
repacking of lakes in part 74; therefore, affirmations of compliance 
with these requirements from the manufacturer of each batch are 
necessary as a condition of certification.
    c. Requirements for repacks of certified lakes. Proposed 
Sec. 80.33(i)(2) would prescribe the format and content of a notice 
claiming certification for a repack of a previously certified batch of 
lake. The notice would be required to contain the name of the lake, as 
prescribed in proposed Secs. 74.50, 74.1050, or 74.2050, and the 
following information for the original certified batch of lake that was 
repacked: FDA acceptance number for the manufacturer's notice claiming 
certification (or the certification lot number, if the batch was 
certified under the old procedure); total color content of the batch; 
color content for each straight color in the batch; and the 
manufacturer's name and place of business. Proposed Sec. 80.33(i)(2) 
would also require the following information about the repacked batch 
of lake: The batch number, weight of batch, total color content, and 
the color content of each straight color in the batch, as well as 
conditions of storage pending certification and proposed uses. This 
information is comparable to that currently required for an application 
for certification of a repack under Sec. 80.21(j)(3).
    Proposed Sec. 80.33(i)(2) would also require statements affirming 
that the batch meets the requirements of 21 CFR parts 74 and 80; that 
the records required by Sec. 80.39, including a representative sample 
of the batch, are available for inspection by FDA; and that the firm 
submitting the notice is the repacker of the batch.
    d. Agency action on the notice. Under proposed Sec. 80.33(j), the 
agency would furnish a response to each notifier within 5 working days 
of receipt of the notice. The agency would review the notice and, if 
the information in the notice was complete and appeared to comply with 
the requirements of parts 74 and 80, would issue an acceptance of the 
notice. Upon issuance of the acceptance, the batch would be a certified 
batch. To facilitate identification of the batch, the acceptance 
document would be assigned a number.
    If the information in the notice claiming certification was 
incomplete or did not appear to comply with the requirements of parts 
74 and 80, the agency would issue a rejection of the notice. Proposed 
Sec. 80.33(j)(2) would state that a batch of lake covered by a rejected 
notice has not complied with the requirements of Sec. 80.31(b) and is 
not a certified batch. The proposed procedure would not provide for 
interim responses by the agency or for amendment of a notice by the 
submitter. The agency recognizes that a rejection of a notice may 
result from an oversight on the part of the submitter, such as the 
inadvertent omission of required information. If the deficiency in the 
notice was such that it could be corrected, the firm could submit a new 
notice that contained all the required information or otherwise 
corrected the deficiency. However, the resubmission would be considered 
a new notice. In addition, under proposed Sec. 80.31(c), the notifier 
would also have the option to request a hearing on the rejection.
4. Recordkeeping Requirements
    The current recordkeeping requirements for certified color 
additives are found in Sec. 80.39 Records of distribution. This section 
requires that the person to whom a certificate is issued keep complete 
records showing the disposal of all the color additive from the batch 
covered by such certificate. The section also specifies the length of 
time the records must be kept (2 years after disposal of the batch) and 
permits FDA access to the facility to check the accuracy of these 
records. It also specifies that these records must be kept separately 
from all other records. The agency is proposing to maintain these 
recordkeeping requirements for certified batches of lakes by modifying 
the language of Sec. 80.39 to conform to the proposed changes in the 
certification procedure for lakes.
    The agency is also proposing to require in Sec. 80.39(b) that a 
firm submitting a notice claiming certification for a batch of lake 
keep additional records that confirm the information submitted in the 
notice. Under proposed Sec. 80.39(b)(1), a manufacturer or repacker of 
a batch of lake certified under Sec. 80.31(b) would be required to 
retain records of all documents that the firm relied upon to establish 
the certified status of the batch of lake. For the manufacturer of a 
lake, such documents would include copies of the notice submitted to 
FDA claiming certification for the batch of lake, the FDA acceptance of 
the notice, the certificate for each batch of straight color used to 
prepare the batch of lake, the FDA acceptance (or, for batches 
certified before the effective date of this final rule, the 
certificate) for each batch of lake used as an ingredient in the batch 
of lake, and the manufacturer's specifications for the substrata used 
to prepare the batch of lake. For the repacker of a lake, such 
documents would include copies of the notice submitted to FDA claiming 
certification for the batch of lake, and the FDA acceptance of the 
notice.
    These records would also include complete reports of any chemical 
analyses performed on the batch or its components, including records of 
analyses that show the total color content of the batch as a percentage 
and, if the batch contains more than one straight color, the color 
content of each straight-color component of the batch of lake. As noted 
above in section VI.B.3.b. of this document, an accurate statement of 
total color content is essential for identification and proper use of a 
lake. Complete records of the analyses would include a method 
description in sufficient detail to allow the analysis to be repeated, 
the experimental data, the final results and a clear description or 
calculations that show how the final results were obtained from the 
experimental data. The agency tentatively concludes that complete 
records of the analyses for total color in a batch of lake are 
necessary to allow the agency to verify the accuracy of the identity of 
the lake.
    For new batches of lakes, proposed Sec. 80.39 would require that, 
for each batch of lake that contains a barium salt, as permitted under 
Secs. 74.1050 and 74.2050, the manufacturer maintain complete records 
of the analyses that show that the batch of lake conforms to the 
specification for soluble barium. Barium is a heavy metal whose safety 
in lakes is based on its insolubility (see section V.A.2.c. of this 
document). In lakes containing barium salts, soluble 

[[Page 8399]]
barium is either deliberately introduced as a precipitant, or could 
form under the conditions of laking. Therefore, the agency tentatively 
concludes that analysis of the batch for soluble barium is necessary to 
ensure the safety of lakes that contain barium salts.
    For new batches of lakes, the agency is proposing that the records 
for the batch would also include the manufacturer's specifications for 
substratum and precipitant ingredients used in the lake, as well as a 
copy of the certificate for each batch of straight color used to 
prepare the lake and a copy of the acceptance of the notice claiming 
certification (or the certificate, during the transition between the 
old and new procedures) for each batch of lake that was used as an 
ingredient in the lake. These additional records would allow the agency 
to verify the information and the affirmations about the identity and 
composition of the lake in the notice claiming certification.
    Under proposed Sec. 80.39(b)(2), the manufacturer or repacker of a 
batch of lake certified under proposed Sec. 80.31(b) would be required 
to retain an 8-ounce sample of the batch. The requirements for taking, 
storing, and labeling this sample are provided in proposed 
Sec. 80.22(b). The requirements are similar to those in existing 
Sec. 80.22 for samples to accompany a request for certification. 
However, proposed Sec. 80.22(b) also specifies when the sample is to be 
taken; storage conditions for the sample; and additional labeling to 
show the total color, the date the sample was taken, and (following FDA 
acceptance of the notice claiming certification) the FDA acceptance 
number.
    The agency is proposing that the timeframes and conditions for 
agency access to these additional records, including the sample of the 
batch retained by the firm, be the same as currently specified in 
Sec. 80.39 for records of distribution for certified color additives.
5. Treatment of Batches of Lakes Pending Certification and After 
Certification
    Current Sec. 80.37  Treatment of batch pending certification and 
Sec. 80.38 Treatment of batch after certification contain requirements 
to ensure that the composition of a batch of color additive subject to 
certification does not change from the composition of the 
representative sample of the batch that was submitted to the agency and 
that formed the basis for the agency's issuance of the certificate for 
the batch; that the batch remains under control of the person 
requesting certification until it has been certified; and that the 
batch is clearly identified as the batch for which certification was 
requested or obtained. The proposed revision of these sections would 
maintain these requirements or comparable requirements for batches of 
lakes to be certified under Sec. 80.31(b).
    a. Treatment of batches of lakes pending certification. Section 
80.37 specifies the storage and labeling requirements for a batch of 
color additive pending certification. The requirements of this section 
are triggered by the act of taking a representative sample from the 
batch of color additive for submission to FDA with the request for 
certification, and they continue until the requested certificate has 
been issued. The agency is proposing to amend Sec. 80.37 to continue 
the requirements and conditions of this section for lakes subject to 
certification under proposed Sec. 80.31(b). Specifically, the agency is 
proposing to amend the description of the sample in Sec. 80.37 to 
include a sample taken and held as a record by the manufacturer or 
repacker of a batch of lake certifiable under proposed Sec. 80.31(b). 
The agency is also proposing to amend Sec. 80.37(b) to specify that the 
batch must be held under the control of the person requesting or 
claiming certification until certified. Finally, the agency is 
proposing to amend Sec. 80.37(c) to specify that the batch must be 
marked in a manner such that there can be no question that the batch 
may not be used until the issuance of the certificate for the batch or, 
for lakes, the issuance of FDA's acceptance of the required notice 
claiming certification.
    b. Treatment of batches after certification. Section 80.38 
specifies the storage, labeling and use requirements, and limitations 
that apply to a batch of color additive after certification. The agency 
is proposing to amend Sec. 80.38 to continue the requirements and 
conditions of this section for lakes under the proposed certification 
procedures in Sec. 80.31(b). Specifically, the agency is proposing to 
amend Sec. 80.38 to divide it into two subsections: (a) Labeling and 
(b) Storage. The agency is also proposing to establish two 
subparagraphs under Sec. 80.38(a) to describe the labeling requirements 
for batches of color additives certified under Sec. 80.31(a) and 
Sec. 80.31(b), respectively. In both cases, the trigger for labeling 
would be notification from FDA that the batch is a certified batch. 
However, a batch certified under proposed Sec. 80.31(b) would be 
identified by labeling it with the FDA acceptance number, rather than 
with the certified lot number. The agency is also proposing to amend 
Sec. 80.38(b) to clarify that the person responsible for the storage 
and use of the batch after certification is the person requesting or 
claiming certification.
6. Color Additive Mixtures
    Current Sec. 80.35 refers to ``straight colors'' in describing the 
ingredients in color additive mixtures to be certified (Sec. 80.35(a)) 
and in color additive mixtures exempt from certification 
(Sec. 80.35(b)). Currently, the term ``straight color'' is defined to 
include lakes. As noted in section III.A.1. of this document, the 
agency is proposing to amend the definition of ``straight color'' to 
exclude lakes and to define a new term ``listed color'' that would 
include both straight colors and lakes. Therefore, the agency is 
proposing a conforming amendment to substitute the term ``listed 
color'' or ``listed colors'' for the term ``straight color'' or 
``straight colors'' in Sec. 80.35.
7. Enforcement Provisions
    a. Limitations of certification. Current Sec. 80.32 specifies 
conditions under which the certificate for a batch of color additive 
expires. The agency is proposing to adapt the provisions of Sec. 80.32 
to the proposed new procedure for certification of lakes.
    As explained in section VI.B.1. of this document, under the 
proposed new certification procedure for lakes, the agency would not 
issue a certificate for a batch of lake. Instead, the certification of 
a batch of lake would rely on the certification of the straight colors 
used in the batch of lake, on the affirmations in the notice claiming 
certification, and on agency acceptance of the notice. The 
certification of a repacked batch of lake would rely on the 
certification of the original batch of lake rather than directly on the 
certification of the straightcolor components of the lake. The agency 
is proposing to amend Sec. 80.32 to clarify that the certification of a 
batch of lake is inextricably linked to the certificates for the 
straight colors used to prepare the lake. As proposed, the expiration 
of the certificate for a batch of straight color would result in the 
expiration of the agency's acceptance of all notices claiming 
certification of batches of lakes made from that batch of straight 
color, including any repacks of such batches.
    The agency is proposing to change the title of Sec. 80.32 from 
``Limitations of Certificates'' to ``Limitations of Certification'' to 
expand the application of Sec. 80.32 to the proposed certification 
procedure for lakes, which would not result in the issuance of a 
certificate by the agency. 

[[Page 8400]]

    Current Sec. 80.32(a) provides that a certificate that is obtained 
through fraud or misrepresentation of a material fact shall not be 
effective, and that any color additive from the batch covered by the 
fraudulently obtained certificate shall be considered to be from an 
uncertified batch. Proposed Sec. 80.32(a) would continue the 
applicability of this provision to batches of lakes certified under the 
proposed new procedure by replacing the term ``certificate'' with the 
phrase ``certificate or acceptance of a notice claiming 
certification''. Proposed Sec. 80.32(a) would also clarify that any 
lake prepared with the color additive covered by the fraudulently 
obtained certificate or acceptance would lose its certification.
    Current Sec. 80.32(b) provides that if, between the time a 
representative sample is taken from a batch of color additive and the 
time a certificate for the batch is received by the person to whom it 
is issued, the color additive becomes changed in composition, the 
certificate shall not be effective, and the changed color additive 
shall be considered to be from an uncertified batch. Proposed 
Sec. 80.32(b) would continue the applicability of this provision to 
batches of lakes certified under the proposed new procedure by amending 
the description of the sample to include a sample retained by a firm 
claiming certification for a batch of lake and by replacing the word 
``a certificate'' by ``a certificate or an acceptance of a notice 
claiming certification.'' The agency is also proposing to amend 
Sec. 80.32(b) to state that if a certificate or acceptance of a notice 
claiming certification for a batch of color additive ceases to be 
effective, then any batch of lake prepared with such color additive is 
also an uncertified batch.
    Current Sec. 80.32(c) provides that if, at any time after a 
certificate is received by the person to whom it is issued, any color 
additive from the batch covered by the certificate becomes changed in 
composition, the certificate expires. Proposed Sec. 80.32(c) would 
continue the applicability of this provision to batches of lakes 
certified under the proposed new procedure by replacing the term ``a 
certificate'' with the phrase ``a certificate or an acceptance of a 
notice claiming certification.'' The agency is also proposing to amend 
the second sentence in Sec. 80.32(c) to indicate clearly that the 
expiration of a certificate or an acceptance of a notice claiming 
certification of a batch of color additive would cause any lake 
prepared with such color additive to be an uncertified batch.
    To allow certain specified uses of the color additive, current 
Sec. 80.32(c) provides three exceptions to the expiration of the 
certificate when a change in composition occurs. A change in 
composition does not cause the certificate to expire if the change in 
composition resulted solely from use of the color additive: (1) For 
coloring a food, drug, or cosmetic; (2) for the purpose of certifying a 
batch of a mixture in which the color additive was used as an 
ingredient; or (3) for use in preparing a batch of a mixture for which 
exemption from certification has been authorized. Proposed 
Sec. 80.32(c) would add another exception to provide that a change in 
composition would not cause the certification of a color additive to 
expire if the change in composition resulted solely from use of the 
color additive as a component or ingredient in a batch of lake for 
which certification was claimed under Sec. 80.31(b) of this chapter. 
This provision would allow the use of certified batches of straight 
color to prepare a lake, or the use of a portion of a certified batch 
of lake as an ingredient in another certified batch of lake.
    As amended, Sec. 80.32(c) would permit any changes in the straight-
color components of a lake that would normally occur during lake 
manufacture under conditions consistent with CGMP. For example, if the 
straight color was a sodium salt (e.g. D&C Yellow No. 10), and the lake 
was prepared with aluminum cation, this provision would allow for the 
change in the cation associated with the straight color from sodium to 
aluminum. However, this provision could not be used to justify a claim 
for certification of a batch of lake containing a straight color that 
had degraded during preparation of the lake. Such a batch of lake would 
not meet the requirement in part 74 that lakes be free from impurities 
other than those named in the specifications, to the extent that such 
impurities may be avoided by CGMP. Therefore, the batch would not 
comply with the conditions of Sec. 80.31(b) and could not be a 
certified batch.
    Current Sec. 80.32(d) provides that a certificate expires if the 
package in which the color additive was closed for shipment or delivery 
is opened. Current Sec. 80.32(d)(1) through (d)(5) specify five 
exceptions to the expiration of the certificate. These exceptions allow 
a package of certified color additive to be opened and the color 
additive used (1) in coloring a food, drug, or cosmetic (subject to 
certain restrictions); (2) for the purpose of certifying a batch made 
by repacking the color additive; (3) for the purpose of certifying a 
batch of a mixture in which the color additive is used as an 
ingredient; (4) for the purpose of preparing a batch of a mixture for 
which exemption from certification has been authorized; and (5) when 
the package is reopened solely for repackaging by the person to whom 
the certificate was issued. Proposed Sec. 80.32(d) would continue the 
applicability of these provisions to certified batches of lakes or 
certified repacks of such batches by replacing the term ``a 
certificate'' by the phrase ``a certificate or an acceptance of a 
notice claiming certification.''
    Current Secs. 80.32(e), (f), and (g) describe additional conditions 
under which a certificate ceases to be effective with respect to a 
package of color additive and under which the color additive is 
therefore considered to be from an uncertified batch. Proposed 
Sec. 80.32(e), (f), and (g) would continue the applicability of these 
provisions to batches of lakes certified under the proposed new 
procedure by replacing the term ``a certificate'' by the phrase ``a 
certificate or an acceptance of a notice claiming certification.''
    Current Sec. 80.32(h) describes the consequences of revocation or 
amendment of the listing or specifications for a color additive. 
Section 80.32(h) states that on the date specified in the order 
effecting the revocation or amendment, all certificates for existing 
batches and portions of batches of the color additive issued under the 
revoked or amended regulations cease to be effective, and any such lots 
of the color additive are regarded as uncertified after the date 
specified unless a new certificate can be and is obtained in conformity 
with the new regulation. Proposed Sec. 80.32(h) would continue the 
applicability of this provision to batches of lakes certified under the 
proposed new procedure by replacing the term ``a certificate'' by the 
phrase ``a certificate or an acceptance of a notice claiming 
certification.'' Proposed Sec. 80.32(h) would also provide that any 
batch of lake prepared from a batch or portion of a batch of color 
additive that was certified under the revoked or amended regulations is 
also regarded as uncertified unless a new certificate is obtained.
    b. Authority to refuse certification. Certification requirements 
are enforced through the provisions of Sec. 80.34 Authority to refuse 
certification service. This section currently provides four conditions 
for refusing certification service to a firm requesting certification. 
Paragraph 80.34(a)(1) authorizes the agency to deny certification 
service to a firm that has ``obtained or attempted to obtain a 
certificate through fraud or misrepresentation of a material fact.''

[[Page 8401]]

The remaining three paragraphs (Sec. 80.34(a)(2), (a)(3), and (a)(4)) 
authorize the agency to deny certification service to a firm that 
violates the recordkeeping requirements of Sec. 80.39 by falsifying the 
required records; failing to keep the records or to make them available 
to the agency; or by refusing to permit duly authorized FDA employees 
full access to inspect the manufacturing facilities, processes and 
formulae involved in the manufacture of color additives and of 
intermediates from which such color additives are derived. Proposed 
Sec. 80.34 would continue the application of these provisions to firms 
certifying batches of lakes under the proposed new procedure by 
amending Sec. 80.34 to replace the phrase ``a certificate'' with the 
phrase ``a certificate or acceptance of a notice claiming 
certification.'' Proposed Sec. 80.34(a)(4) would also authorize FDA to 
examine processes and formulae for substrata, as substances from which 
color additives are derived.

C. Amendments to Other Regulations

1. Listings in Part 74
    a. Listings for FD&C Red No. 40 lakes. Except for FD&C Red No. 40, 
all the straight colors used in lakes were provisionally listed in 
1960. FD&C Red No. 40 was never provisionally listed and, when FD&C Red 
No. 40 was listed (permanently) in 1971 (food and drugs: 36 FR 23552, 
December 10, 1971) and 1975 (cosmetics: 39 FR 28278, August 6, 1974, 
and 39 FR 44198, December 23, 1974), the lakes of FD&C Red No. 40 were 
included, for convenience, in Secs. 74.340, 74.1340, and 74.2340. These 
permanent listings for FD&C Red No. 40 lakes cross-reference the 
specifications and labeling requirements in the provisional listings 
for lakes. For consistency, the agency is proposing to move the current 
listings of lakes of FD&C Red No. 40 in Secs. 74.340, 74.1340, and 
74.2340 to Secs. 74.50, 74.1050, and 74.2050, respectively, to conform 
the permanent listing of the lakes of FD&C Red No. 40 to the permanent 
listings for other lakes.
    b. Reference to lakes in listings for straight colors. The proposed 
permanent listings for lakes (Secs. 74.50, 74.1050, and 74.2050) would 
specify the straight colors that are permitted as components of a lake. 
The agency tentatively concludes that the regulations for the straight 
colors should specify that lakes made with the straight color must 
conform to the requirements for lakes (Secs. 74.50, 75.1050, or 
74.2050, as appropriate). Therefore, the agency is proposing to amend 
the listings in part 74, subpart A, for the straight colors used to 
prepare lakes for food use to specify that ``lakes made with (name of 
straight color) shall conform to the requirements of Sec. 74.50''; to 
amend the listings in part 74, subpart B, for the straight colors used 
to prepare lakes for drug use to specify that ``lakes made with (name 
of straight color) shall conform to the requirements of Sec. 74.1050''; 
and to amend the listings in part 74, subpart C, for the straight 
colors used to prepare lakes for cosmetic use to specify that ``lakes 
made with (name of straight color) shall conform to the requirements of 
Sec. 74.2050.''
    c. Listings for eye-area use of lakes. In 1994, the agency 
permanently listed the aluminum lakes on alumina of the straight colors 
FD&C Blue No. 1 and FD&C Red No. 40 (February 16, 1994, 59 FR 7635) and 
FD&C Yellow No. 5 (November 29, 1994, 59 FR 60893), for use in drugs 
and cosmetics intended for use in the area of the eye. Because 
Sec. 81.1 specifically precludes use of provisionally listed lakes in 
eye-area products, these lakes were included in the permanent listings 
of the straight color. The agency tentatively concludes that it is 
appropriate to include the eye-area uses of lakes with the other 
permanently listed uses of lakes and is therefore proposing to move 
these eye-area uses from the permanent listings for the straight colors 
to Secs. 74.1050 and 74.2050.
2. Color Additive Labeling
    Currently, provisionally listed lakes are subject to the general 
labeling requirements for color additives in Sec. 70.25. FDA is 
proposing to continue the applicability of these requirements to 
permanently listed lakes by including a provision in proposed 
Secs. 74.50, 74.1050, and 74.2050 to prescribe that the label of a lake 
conform to the requirements of Sec. 70.25.
    To reflect the proposed deletion of the provisional listings for 
color additives, the agency is also proposing to amend Sec. 70.25(a) by 
removing the reference to part 81. As a result of the proposed change 
in the definition of ``straight color'' and the proposed new definition 
of ``listed color,'' the agency is proposing to maintain the general 
labeling requirements for color additives by amending Sec. 70.25(a)(1) 
and (a)(3) to replace the term ``straight color'' with the term 
``listed color.'' As amended, Sec. 70.25(a)(1) would require the label 
of a package of lake to include the name of the lake, as prescribed in 
part 74 (Secs. 74.50, 74.1050, or 74.2050).
    As a result of the proposed new certification procedure for batches 
of lakes, the agency is also proposing to amend Sec. 70.25(a)(3), which 
requires that the label of certified colors that are subject to a 
tolerance (quantitative limitation on use) bear directions to prevent 
products to which the color may be added from exceeding the tolerance. 
As amended, Sec. 70.25(a)(3) would provide that, where regulations 
impose a tolerance for a general or specific use of a straight color, 
the amount of a straight color present in a lake would be included in 
the total amount of the straight color.
    In addition, the agency is proposing to amend Sec. 70.25(d) Special 
labeling for color additives not exempt from certification to establish 
separate labeling requirements for color additives subject to the 
certification procedures of Sec. 80.31(a) and lakes subject to the 
certification procedures of Sec. 80.31(b). Proposed Sec. 70.25(d)(1) 
would apply to color additives subject to certification under 
Sec. 80.31(a) and would incorporate the provisions of current 
Sec. 70.25(d). Proposed Sec. 70.25(d)(2) would prescribe special 
labeling requirements for lakes subject to certification procedures 
under Sec. 80.31(b). The proposed paragraph would require that the 
labeling for such lakes include the total color content of the lake, 
the amount of color contributed by each straight-color component of the 
lake, and FDA's acceptance number for the notice claiming certification 
of the batch. The information on the total color content and content of 
each straight color in the lake would enable the user of the lake to 
comply with any quantitative limitations on the use of the straight-
color component of a lake. This information would also assist the user 
in the formulation of products using the lake. The inclusion of the FDA 
acceptance number for the notice claiming certification for the batch 
would facilitate agency verification of the records and other 
information for the batch.
3. Product Labeling
    a. Food ingredient labeling. i. Statutory authority. Currently, 
lakes are provisionally listed colors subject to certification. 
Therefore, under section 403(i) of the act (21 U.S.C. 343), as amended 
by the Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535) 
(the NLEA), lakes must be listed as ingredients on the label of food 
products that contain them. Before the NLEA was enacted, the act 
provided that color additives added to food need not be declared 
individually by their common or usual names but could be designated by 
the collective term ``colorings.'' In 1990, the NLEA amended section 
403(i) of the act to exempt from label 

[[Page 8402]]
declaration only colors not required to be certified. To implement 
amended section 403(i), the agency revised its labeling regulations in 
Sec. 101.22 by adding new paragraph (k), which became effective on May 
8, 1993. Under Sec. 101.22(k)(1), the lake of a color additive subject 
to certification must be individually identified on the food label. 
Because all lakes for food use are made from straight colors subject to 
certification and are themselves certified color additives, the 
presence of a lake in a food product must always be individually 
identified on the label of the product under Sec. 101.22(k)(1). The 
agency is now proposing to list lakes permanently as color additives 
subject to certification. Therefore, in accordance with section 403(i) 
of the act (21 U.S.C. 343(i)), the agency is proposing to retain the 
requirement that lakes be declared on the food label under their 
individual names rather than as ``colorings.''
    Section 721(b)(3) of the act (21 U.S.C. 379e(b)(3)) provides that 
regulations for the listing of a color additive ``shall, to the extent 
deemed necessary * * * to assure the safety of the use or uses for 
which a particular color additive is listed, prescribe the conditions 
under which such additive may be safely employed for such use or uses 
(including, but not limited to * * * directions or other labeling or 
packaging requirements for such additive).'' The straight colors FD&C 
Yellow No. 5 and FD&C Yellow No. 6 have been reported to cause 
hypersensitivity in some individuals. Declaration of the lakes of FD&C 
Yellow No. 5 and FD&C Yellow No. 6 on the label of foods that contain 
them will provide the means for consumers who are sensitive to these 
color additives to identify the foods that contain them and thereby 
avoid suffering a reaction. Therefore, the agency tentatively concludes 
that such a label declaration requirement is necessary.
    Label declaration of the straight color FD&C Yellow No. 5 is 
required under Sec. 74.705 for all foods that contain this color 
additive, including butter, cheese, and ice cream (foods exempted under 
section 403(k) of the act (21 U.S.C. 343(k)) from the requirement to 
declare the presence of certified color additives). In the Federal 
Register of July 21, 1995 (60 FR 37611), the agency published a 
proposal to require declaration of FD&C Yellow No. 6 on the labels of 
butter, cheese, and ice cream (hereinafter referred to as the July 1995 
proposal). Declaration of FD&C Yellow No. 6 in other foods is already 
required under Sec. 101.22(k)(1). The agency notes that both its 
original proposal to require the labeling of FD&C Yellow No. 5 in foods 
and ingested drugs (42 FR 6835, February 4, 1977) and the pending 
proposal to require the labeling of FD&C Yellow No. 6 in butter, 
cheese, and ice cream refer to the need for label declaration of the 
presence of the color additive in food for humans--whether added as a 
straight color, a mixture, or a lake--to enable persons intolerant to 
the color additive to minimize exposure to it. Therefore, the agency 
tentatively concludes that the lakes of FD&C Yellow No. 5 and FD&C 
Yellow No. 6 should be subject to the same label declaration 
requirements for foods as the straight colors. Accordingly, this 
proposal modifies the July 1995 proposal to include lakes.
    Proposed Sec. 74.50(e)(2) would require that the label of food 
products for human use that contain a lake declare the presence of the 
lake in accordance with Sec. 101.22(k) of this chapter. Proposed 
Sec. 74.50(e)(3) would require that the labels of butter, cheese, and 
ice cream that contain a lake of FD&C Yellow No. 5 or FD&C Yellow No. 6 
declare such lake in the list of ingredients.
    ii. Format. Currently, Sec. 101.22(k)(1) provides for the 
declaration of certified color additives, including lakes, in the 
ingredient listing on the food label and cites part 74 or 82 as the 
source of the name of such color additive. In this rulemaking, the 
agency is proposing to list lakes permanently in part 74 and to remove 
parts 81 and 82. Therefore, the agency is proposing to remove the 
reference to part 82 as a source of the name for a certified color 
additive for declaration on the food label.
    Section 101.22(k)(1) states that it is not necessary to include the 
``FD&C'' prefix or the term ``No.'' in the declaration of a color 
additive on the food label, but that the term ``Lake'' must be included 
in the declaration of a lake. However, the example given in 
Sec. 101.22(k)(1) (``Blue 1 Lake'') to illustrate the declaration of a 
lake does not include the identity of the precipitant cation, although 
the precipitant cation is part of the listed name of the lake under 
current Sec. 82.51. In addition, in this rulemaking, the agency is 
proposing in Sec. 74.50 to include the substratum as well as the 
precipitant cation in the listed name of a lake.
    The agency tentatively concludes that the current abbreviated 
nomenclature (e.g., Blue 1 Lake) for food ingredient labeling is still 
appropriate and that the inclusion of the identity of the precipitant 
cation and substratum in the name of the lake on the food label is 
unnecessary and may be confusing to consumers. Inclusion of these 
components of lakes as part of the name of the lake in the ingredient 
list would greatly lengthen the name of the lake on the food label 
without providing any additional information about the color additive, 
since the agency is proposing to permit only the aluminum cation and 
the substratum alumina in lakes for food use.
    As discussed in section IV.A.1.d. of this document, the agency is 
also proposing in new Sec. 74.50 to allow the use of more than one 
straight color in a lake. Accordingly, the agency is proposing to amend 
Sec. 101.22(k)(1) to require that all straight colors used to prepare a 
lake be included in the name of the lake. Amended Sec. 101.22(k)(1) 
would also specify that it is not necessary to include the name of the 
precipitant cation or the substratum in the name of a lake when listing 
it as an ingredient in a food product. Thus, a lake would be identified 
on a food label by a name consisting of the names of the straight 
colors (in descending order of predominance) present in the lake 
(without the ``FD&C'' designation or the term ``No.'') followed by the 
word ``Lake.'' For example, a lake that contains 10 percent FD&C Yellow 
No. 5, 5 percent FD&C Blue No. 1, the aluminum cation, and alumina 
substratum would be declared on the food label as ``Yellow 5 and Blue 1 
Lake.''
    b. Cosmetic ingredient labeling. Currently, Sec. 701.3 requires 
that the label of each package of a cosmetic bear a declaration of the 
name of each ingredient in descending order of predominance. Section 
701.3(c) also designates, in order of priority, the sources from which 
the names of cosmetic ingredients are to be derived for the purpose of 
declaration of ingredients. Under Sec. 701.3(c)(1), if FDA has 
established a name for the ingredient in Sec. 701.30, that name is 
used. However, Sec. 701.3(c)(1) does not cite the color additive 
regulations as the preferred source for names of color additives. The 
agency is proposing to correct this oversight by amending Sec. 701.3(c) 
to include the color additive listings in parts 73 and 74 as the 
preferred source of names for the declaration of ingredients on the 
cosmetic label.
    Currently, under Sec. 701.3(c)(2) (21 CFR 701.3(c)(2)), a lake is 
declared on the cosmetic label by the name under which it is listed in 
the CTFA Cosmetic Ingredient Dictionary, 2d ed. (1977). This name is 
the same as the listed name of the color additive, which, under 
Secs. 82.51, 82.1051, and 82.2051, is formed from the name of the 
straight color, the name of the precipitant 

[[Page 8403]]
cation, and the word ``lake.'' As discussed in previous sections of 
this document, the agency is proposing in Sec. 74.2050(c) to change the 
listed name of a lake to include the name of the substrata used in the 
lake, and is also proposing to allow the use of more than one straight 
color to make a lake. The agency recognizes that these proposed changes 
would result in a long listed name for a lake. As with food labels, the 
agency is concerned that the additional information that such a name on 
a cosmetic label would provide to consumers would be overshadowed by 
consumer confusion about the identity and composition of the color 
additive.
    Unlike lakes added to food (which, under the proposed regulation, 
would be permitted to contain only one cation precipitant (aluminum) 
and one substratum (alumina)), however, lakes added to cosmetics would 
continue to contain a range of possible cation precipitants and 
substrata. The straight color and the substrata are the principal 
components of the lake by weight, making up over 95 percent of the 
total weight of the lake. Currently, the name of a lake provides only 
the identity of the straight color and the precipitant. The complete 
name of a lake would provide additional information to consumers about 
the substrata present in lakes. On the other hand, the space available 
for ingredient declaration on a cosmetic label is limited, and under 
the proposed new nomenclature that would be required by Sec. 74.2050, 
the name of a lake would occupy a significantly greater amount of space 
than currently. Furthermore, the amount of space on the label that 
would be allocated to declaring the presence of a lake would give undue 
prominence to the lake as an ingredient and overshadow the other 
ingredients of the cosmetic product, although lakes are not necessarily 
more important to the consumer.
    Therefore, the agency tentatively concludes that the abbreviated 
nomenclature permitted for declaring lakes as ingredients on the food 
label under Sec. 101.22(k) should be permitted for cosmetic labels as 
well. The agency believes that the abbreviated name would provide 
consumers with more understandable information about the identity of 
the color additive because it would clearly identify the ingredient as 
a color additive and highlight the color component of the lake, which 
is its primary characterizing feature from the consumer's point of 
view. The agency tentatively finds that adopting uniform nomenclature 
for color additives, including lakes, on food and cosmetic ingredient 
labels would assist consumers in identifying these ingredients as color 
additives. Therefore, the agency tentatively concludes that the 
extension of abbreviated nomenclature for ingredient labeling of lakes 
to cosmetics as well as foods will provide maximum benefit to 
consumers.
    For consistency, the agency also tentatively concludes that this 
abbreviated nomenclature for cosmetic ingredient labeling should apply 
to all certified color additives, not just to lakes. Currently, 
straight colors are declared on the cosmetic label by the listed name 
of the straight color (e.g., FD&C Blue No. 2). However, as discussed 
above, under Sec. 101.22(k) the agency permits the use of abbreviated 
names for identifying straight colors in the ingredient statement on 
the food label. The agency tentatively concludes that the abbreviated 
name now being used on the food label (the listed name without the 
prefix ``FD&C'' or ``D&C,'' and without the term ``No.'') would meet 
the purpose of ingredient declaration on the cosmetic label to prevent 
consumer deception and to facilitate value comparisons (38 FR 28912, 
October 17, 1973).
    However, for cosmetics, the prefix ``Ext.'' would still be required 
as part of the abbreviated name to uniquely identify different color 
additives. For example, D&C Yellow No. 7 (21 CFR 74.1707 and 74.2707) 
and Ext. D&C Yellow No. 7 (21 CFR 74.1707a and 74.2707a) are different 
chemical compounds, although they are both listed as color additives 
for use in externally applied drug and cosmetic products. Under the 
proposed abbreviated nomenclature, Ext. D&C Yellow No. 7 would be 
declared as Ext. Yellow 7, whereas D&C Yellow No. 7 would be declared 
as Yellow 7.
    Adopting this abbreviated nomenclature for ingredient declaration 
of certified colors on cosmetic labels would eliminate the current 
inconsistency between the nomenclature used to identify certified 
colors on food labels and the nomenclature used on cosmetic labels, as 
well as any resulting consumer confusion. Therefore, the agency is 
further proposing to adopt as an option, for the purpose of declaring 
certified colors as ingredients on the labels of cosmetics, the same 
abbreviated nomenclature currently permitted under Sec. 101.22(k) for 
declaring certified colors on the food label, except that the ``Ext.'' 
prefix must be included where applicable. For example, the color 
additive D&C Red No. 28 could be declared on the cosmetic label as 
``Red 28,'' and a lake containing 10 percent FD&C Yellow No. 5, 5 
percent D&C Red No. 28, the precipitant cations aluminum and calcium, 
and 50 percent barium sulfate and 35 percent rosin, could be declared 
on the cosmetic label as ``Yellow 5 and Red 28 Lake.'' The requirement 
that the prefix ``Ext.'' be included on cosmetic labels would not 
create an inconsistency with the nomenclature for food labels because, 
by definition, ``Ext.'' color additives are for external use and cannot 
be used in foods.
    To accomplish the changes discussed above, the agency is proposing 
to amend Sec. 701.3(c) by establishing new paragraphs (c)(1)(i) and 
(c)(1)(ii). Proposed paragraph (c)(1)(ii) would incorporate the 
existing citation to Sec. 701.30 as a source of names. Proposed 
paragraph Sec. 701.30(c)(1)(i) would identify the color additive 
regulations in parts 73 and 74 as the preferred source of names for 
color additives. This proposed paragraph would further state that for 
color additives listed in part 74 it is not necessary to include the 
prefix ``FD&C'' or ``D&C'' or the term ``No.'' in the ingredient 
declaration, but that the prefix ``Ext.'' shall be included in the 
declaration. For lakes, it would also not be necessary to include the 
identity of precipitant cations or substrata, but the term ``Lake'' 
would have to be included in the name.
    c. Labeling of drug products. Under Secs. 201.20 (a) and (b) (21 
CFR 201.20 (a) and (b)) and Sec. 74.1705(c), certain over-the-counter 
and prescription drug products intended for human use must declare the 
presence of FD&C Yellow No. 5 as a color additive. The regulations 
specify that the labeling for these drug products shall bear a 
statement such as ``Contains FD&C Yellow No. 5 (tartrazine) as a color 
additive'' or ``Contains color additives including FD&C Yellow No. 5 
(tartrazine),'' and prescribe a more detailed warning that must be 
included in the ``Precautions'' section of the labeling.
    Under the July 1995 proposal, the labels of certain over-the-
counter and prescription drug products would be required to declare the 
presence of FD&C Yellow No. 6 as a color additive. The agency had 
previously published a final rule adopting the same requirement for 
such drug products (51 FR 41765, November 19, 1986), but subsequently, 
in compliance with a stipulation for the dismissal of a lawsuit 
challenging the 1986 final rule, the agency published a notice in the 
Federal Register of December 6, 1988 (53 FR 49138), announcing that the 
requirement would not be enforced pending a reproposal of the action. 

[[Page 8404]]

    The provisional listings of the lakes of FD&C Yellow No. 5 
(Sec. 82.705) and FD&C Yellow No. 6 (Sec. 82.706) do not contain any 
reference to the declaration of these lakes in drug products. However, 
FDA's proposal to require the labeling of FD&C Yellow No. 5 in foods 
and ingested drugs (42 FR 6835, February 4, 1977) explicitly states 
that ``a label declaration of the presence of FD&C Yellow No. 5 in food 
for humans, whether added as the straight color, a mixture, or a lake, 
would enable persons intolerant to FD&C Yellow No. 5 to minimize 
exposure to the color.'' The July 1995 proposal contains almost 
identical language in the foods section of the proposal (60 FR 37611 at 
37613 to 37614). Although these proposals were silent as to whether the 
labeling requirement would encompass all forms (straight color, 
mixture, or lake) of the color additive when added to drugs, the safety 
issue necessitating such labeling in drugs is the same as for foods. 
Therefore, the agency tentatively concludes that the presence of FD&C 
Yellow No. 5 should be declared as prescribed by Sec. 74.1705 (c)(2) 
and (c)(3) and by Sec. 201.20 (a) and (b) when a lake of FD&C Yellow 
No. 5 is used in these products, and that the presence of FD&C Yellow 
No. 6 should be declared as prescribed by proposed Secs. 74.1706(c)(2) 
and 201.20(c) when a lake of FD&C Yellow No. 6 is used. Accordingly, 
this proposal modifies the July 1995 proposal to include lakes of FD&C 
Yellow No. 5 and FD&C Yellow No. 6. The agency notes that the 
declaration of FD&C Yellow No. 5 and FD&C Yellow No. 6 in these drug 
products is intended as a warning statement about the presence of these 
color additives, not as an ingredient declaration.
    To minimize confusion, the agency is proposing that the declaration 
for the presence of a lake of FD&C Yellow No. 5 in drug products should 
be the same as that required for the straight color in Secs. 74.1705(c) 
and 201.20. Therefore, the agency is proposing to require in 
Sec. 74.1050(e)(2) that drugs that contain a lake of FD&C Yellow No. 5 
be labeled in accordance with Sec. 74.1705 (c)(2) and (c)(3). 
Similarly, the agency is proposing to require in Sec. 74.1050(e)(3) 
that drugs that contain a lake of FD&C Yellow No. 6 be labeled in 
accordance with proposed Sec. 74.1706(c)(2). The agency is also 
proposing to amend Sec. 201.20 to state that a drug product that 
contains a lake of FD&C Yellow No. 5 or a lake of FD&C Yellow No. 6 is 
subject to the same labeling requirements as a drug product that 
contains the straight color. Finally, the agency is proposing to amend 
Sec. 74.1705 (c)(2) and (c)(3) to clarify that drugs made with a lake 
of FD&C Yellow No. 5 are subject to the same label declaration 
requirements as drugs made with the straight color, and to modify 
proposed Sec. 74.1706(c)(2) to clarify that drugs made with a lake of 
FD&C Yellow No. 6 are subject to the same label declaration 
requirements as drugs made with the straight color.
    Under the current regulations, certain drug products that are also 
cosmetics, such as antibacterial mouthwashes and fluoride toothpastes, 
need not comply with the label declaration requirements for FD&C Yellow 
No. 5 in Secs. 74.1705(c) and 201.20, provided that they comply with 
the ingredient labeling provisions for cosmetics in Sec. 701.3. The 
pending July 1995 proposal for declaration of FD&C Yellow No. 6 in 
ingested drugs contains the same proviso. The agency is proposing to 
allow the labeling of such drug/cosmetic products that contain lakes of 
FD&C Yellow No. 5 or FD&C Yellow No. 6 to use the abbreviated 
nomenclature for ingredient declaration of lakes in proposed 
Sec. 701.3(c)(1), which is discussed in section VI.C.3.b. of this 
document.

4. Other Amendments

    As a result of the proposed change in the definition of ``straight 
color'' and the proposed new definition of ``listed color,'' the agency 
is also proposing to amend Secs. 70.20, 73.1, and 73.1001 to replace 
the term ``straight color'' with the term ``listed color.''
    As a result of the deletion of the provisional listings (parts 81 
and 82), the agency is also proposing to amend Sec. 178.3297(d) by 
removing the references to parts 81 and 82.

VII. Summary of Information Requested

    To protect the confidentiality of the requested identity and 
process information, interested parties may submit such information, as 
well as reference samples of rosin products, directly to the Office of 
Cosmetics and Colors (address above).

A. In Situ Manufacturing Processes

    As discussed in section V.A.2. of this document, the agency is 
aware that some substrata, including aluminum benzoate, alumina, barium 
sulfate (blanc fixe), and gloss white, may be currently prepared in 
situ during the manufacture of lakes. The agency is proposing 
conditions for the in situ preparation of alumina and aluminum benzoate 
as substrata and is requesting, as comments on this proposal, 
information on appropriate methods of preparation and ingredient 
specifications for barium sulfate produced in situ. If such comments 
are received, the agency will consider modifying the proposal to permit 
the in situ preparation of barium sulfate as a substratum.

B. Identity and Specifications for Rosin

    As discussed in section V.A.2.k. of this document, the agency is 
requesting, as comments on this proposal, information (e.g., a 
manufacturer's product specification sheet or analytical data sheet) 
about identity and specifications for any type of rosin that does not 
meet the identity and specifications proposed in this document, but 
that is currently used as the substratum ``rosin'' under Secs. 82.1051 
or 82.2051. The agency is also requesting a 5-pound reference sample of 
each type of rosin identified in a comment. Comments should identify 
the specific type(s) of rosins used by the lake manufacturer and 
describe any treatment of the rosin prior to incorporation in a lake. 
Furthermore, the agency requests data concerning the dermal safety of 
any rosin intended for use as a diluent in color additives for 
externally applied drug use.
    If the agency receives satisfactory information for additional 
types of rosin, the agency will expand the definition of rosin in its 
final action on this rulemaking to provide for the use of the 
additional products as substrata in lakes for drug or cosmetic use. In 
addition, to alleviate the concerns raised by literature reports of 
allergic reactions and dermal irritation caused by some forms of free 
rosin, the agency is requesting information on the safety of rosin as a 
diluent in color additive mixtures used in externally applied drugs. If 
the requested data are received and they demonstrate that rosin used as 
a diluent in externally applied drugs is safe, the agency will consider 
listing rosin for such use in the final rule.

C. Anions in Precipitants

    As discussed above, the agency is proposing to allow only the 
anions chloride (Cl-1) and sulfate (SO4-2) for use as 
components of precipitants. However, because the provisional listing 
regulations did not specify the anions that could be used in lakes, the 
agency is requesting comments on the use of other anions in the 
preparation of lakes for food, drug, or cosmetic use. This information 
should include data to document the current use of such anions in 
preparing lakes and to demonstrate their safety for such use. If the 
agency receives information to confirm the current safe use of anions 
other than chloride and sulfate in lakes, the agency will consider 
listing these anions in the final rule. 

[[Page 8405]]


VIII. Effective Date

    Section 701(e) of the act (21 U.S.C. 371(e)) allows 30 days for the 
filing of objections to a final rule listing a color additive and 
states that such a final rule may not become effective until the period 
for filing objections is over. Thus, the earliest possible effective 
date for a final rule listing a color additive is 31 days after 
publication. FDA typically sets a longer effective date for changes in 
labeling requirements.
    In accordance with section 701(e) of the act, the agency is 
proposing that the final rule resulting from this proposal become 
effective 31 days following its publication, except for the proposed 
provisions of Secs. 201.20, 74.1050(e), 74.1705(c), and 74.1706(c)(2) 
concerning declaration of lakes of FD&C Yellow No. 5 and FD&C Yellow 
No. 6 on the labels of certain drug products, and the proposed 
provisions of Secs. 74.50(e)(3) and 74.706(d)(2) concerning declaration 
of lakes of FD&C Yellow No. 6 on the labels of butter, cheese, and ice 
cream. FDA is proposing that these provisions, which are part of the 
rulemaking initiated by the July 1995 proposal (as modified by this 
proposal), become effective when the final rule resulting from that 
proposal takes effect.
    Although this proposal contains changes in the ingredient labeling 
provisions applicable to cosmetics, the proposed abbreviated 
nomenclature for declaration of lakes as ingredients in these products 
is optional, and manufacturers may continue to use the old labeling 
nomenclature if they wish. Therefore, FDA tentatively concludes that 
the amendments to the labeling regulations for lakes in cosmetics do 
not necessitate a delay in the effective date of the final rule.

IX. Inspection of Documents

    The documents that FDA considered and relied upon in developing 
this proposal are available for inspection at the Center for Food 
Safety and Applied Nutrition by appointment with the information 
contact person (address above). As provided in Sec. 71.15 (21 CFR 
71.15), the agency will delete from the documents any materials that 
are not available for public disclosure before making the documents 
available for inspection.

X. Environmental Impact

    The agency has determined under 21 CFR 25.24(b)(3) 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.

XI. Paperwork Reduction Act

    This proposed rule contains collections of information that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Therefore, in 
accordance with 44 U.S.C. 3506(c)(2)(B) and 5 CFR part 1320, FDA is 
providing below the title, description, and respondent descriptions for 
the collections of information contained in this proposal along with an 
estimate of the resulting annual collection of information burden. 
Included in the estimate is the time needed to review instructions, to 
gather the required information, and to disclose the information.
    FDA invites comments on the following:
    (1) Whether the proposed collection of information is necessary for 
the proper performance of the functions of the agency, including 
whether the information will have practical utility;
    (2) The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
    (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and
    (4) Ways to minimize the burden of the collection of information on 
those who are to respond, including through the use of automated 
collection techniques, where appropriate, or other forms of information 
technology.
    Title: Certification and Labeling Requirements for Color Additive 
Lakes.
    Description: Section 721(c) of the act requires the certification 
of color additives where a certification requirement is necessary in 
the interest of the public health. Currently, lakes are subject to 
certification under Secs. 80.21 and 80.31 and recordkeeping as required 
in Sec. 80.39. The proposed rule would establish a new simplified 
procedure for certification of batches of lakes. Under Sec. 80.33 of 
the proposed rule, the manufacturer or repacker of a lake would submit 
a notice claiming certification, in lieu of a request for 
certification. The notice would contain information about the 
ingredients and chemical composition of the batch. The manufacturer or 
repacker would be required to keep records, including a sample taken 
from the batch, to document the information in the notice. After 
certification, the manufacturer or repacker would be required to keep 
records of the disposition of the batch. The proposal would also 
require that these records be made available to FDA upon request. 
Because most of the records that would be required by the proposed rule 
are already kept in the usual course of business, the agency believes 
that the proposed provisions will add only a minor additional record 
retention burden for firms subject to the proposed provisions.
    Section 721(b)(3) of the act provides that a color additive 
regulation shall prescribe the conditions under which the additive may 
be safely employed for use in foods, drugs, or cosmetics, including any 
labeling or packaging requirements necessary to ensure the safety of 
the additive. The presence of FD&C Yellow No. 5 or FD&C Yellow No. 6 in 
food has been reported to cause allergic-type reactions. To ensure that 
consumers who are sensitive to these color additives will be able to 
identify and avoid them, the agency is proposing to require in 
Sec. 74.50(e)(3) that lakes of FD&C Yellow No. 5 and FD&C Yellow No. 6 
that are used as ingredients in butter, cheese, and ice cream be 
declared on the labels of these foods. (Declaration of these lakes in 
all foods is already required both by statute and regulation.) However, 
because the agency is unaware of any current use of lakes of FD&C 
Yellow No. 5 or FD&C Yellow No. 6 in butter, cheese, or ice cream, the 
agency tentatively concludes that no burden would result from this 
proposed change.
    Proposed Sec. 701.3(c)(1)(i) changes the reference for the names 
under which color additives, including lakes, are declared on the 
cosmetic label, and provides for the optional use of abbreviated 
nomenclature for the declaration of color additives as ingredients on 
the cosmetic label. Proposed Sec. 701.3(c)(1)(i) would also allow 
continued use of the current nomenclature, however. The agency does not 
anticipate that cosmetic manufacturers will change their labels 
immediately to take advantage of the abbreviated nomenclature; rather, 
the agency expects that manufacturers will start using the abbreviated 
nomenclature when they institute a label change for some other reason. 
Therefore, the agency tentatively concludes that proposed 
Sec. 701.3(c)(1)(i) would introduce no startup costs or other burden.
    To avoid double-counting, certain labeling provisions in this 
proposal have not been included in the burden estimate because they 
merely cross-reference labeling requirements contained in other 
regulations. Accordingly, proposed Secs. 74.50(e)(1) and (e)(2), 
74.1050(e), and 74.2050(d) do 

[[Page 8406]]
not appear in the burden estimate table. Provisions that merely 
continue existing labeling requirements, such as proposed 
Sec. 101.22(k)(1), also have not been included in the burden estimate 
for this proposal.
    Other proposed labeling changes do not constitute collections of 
information because they provide for disclosure of information supplied 
by FDA. Proposed Secs. 201.20, 74.1705(c)(2) and (c)(3), and 
74.1706(c)(2) would require disclosure of the presence of FD&C Yellow 
No. 5 and FD&C Yellow No. 6 on the labels and in the labeling of 
certain drug products. The proposed regulations specify the wording of 
the required disclosures. Also, proposed Sec. 70.25(d)(2) would require 
disclosure, on the package label of the lake, of the number assigned by 
FDA to its acceptance of the notice claiming certification for the 
batch of lake. These labeling requirements provide for ``public 
disclosure of information originally supplied by the Federal government 
to the recipient for the purpose of disclosure to the public'' and are, 
therefore, exempt from OMB review under 5 CFR 1320.3(c)(2). Finally, 
some proposed requirements have been excluded from the burden estimate 
because the agency tentatively concludes that the resources necessary 
to comply with these requirements would be expended by businesses in 
the normal course of their activities and that the reporting, 
recordkeeping, or disclosure activities required by the proposed 
regulation are, thus, usual and customary (5 CFR 1320.3(b)(2)). For 
example, the information on percent total color and percent color from 
each straight color used in a batch of lake that must appear on the 
package label of the lake under proposed Sec. 70.25(d)(2)(i) and (ii) 
is needed by the purchaser of the lake to properly formulate the 
purchaser's food, drug, or cosmetic product. Therefore, as a matter of 
business necessity, a manufacturer or repacker would obtain and 
disclose this information to clients, regardless of FDA requirements.
    Description of Respondents: Businesses, including small businesses.

                                        Estimated Annual Reporting Burden                                       
----------------------------------------------------------------------------------------------------------------
                                                                                                        Total   
                                                           Annual     Total                           Operating 
                CFR Section                  Number of   Frequency    Annual   Hours per    Total        and    
                                            Respondents     per     Responses   Response    Hours    Maintenance
                                                          Response                                      Costs   
----------------------------------------------------------------------------------------------------------------
21 CFR 74.50(e)(3)........................           0           0          0       0             0           0 
21 CFR 80.33..............................          20          80      1,600       0.25        400     $48,000 
21 CFR 701.3(c)(1)(i).....................           0           0          0       0             0           0 
                                                                                         -----------------------
    Totals................................  ...........  .........  .........  .........        400      48,000 
----------------------------------------------------------------------------------------------------------------


                                      Estimated Annual Recordkeeping Burden                                     
----------------------------------------------------------------------------------------------------------------
                                                                   Annual       Total                           
                  CFR Section                     Number of     Frequency of    Annual     Hours per     Total  
                                                Recordkeepers  Recordkeeping   Records   Recordkeeper    Hours  
----------------------------------------------------------------------------------------------------------------
21 CFR 80.22..................................           20              1           20         2.65          53
21 CFR 80.39..................................           20              1           20        37.35         747
    Totals....................................  .............  .............  .........        40            800
----------------------------------------------------------------------------------------------------------------

    The agency expects that the number of respondents and the annual 
burden hours will not change significantly over succeeding years 
because it believes that the use of lakes in foods, drugs, and 
cosmetics will remain constant. There are no anticipated capital or 
startup costs associated with the proposed information collection 
requirements.
    The agency has submitted copies of the proposed rule to OMB for 
review of the portions of the proposal that are within the ambit of the 
Paperwork Reduction Act of 1995. Interested persons are requested to 
send comments regarding information collection by April 3, 1996, but 
not later than May 3, 1996, to the Office of Information and Regulatory 
Affairs, OMB, New Executive Office Building, rm. 10235, Washington, DC 
20503, ATTN: Desk Officer for FDA.

XII. Comments

    As noted in section XI. of this document, interested parties may, 
on or before May 3, 1996, submit to the Office of Information and 
Regulatory Affairs, OMB (address above) written comments regarding the 
collections of information contained in this proposal. For other issues 
in the proposed rule, interested persons may, on or before June 3, 
1996, submit to the Dockets Management Branch (address above) written 
comments regarding this proposal. Four copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number of the rulemaking or rulemakings 
to which the comment is relevant. Comments on modifications to the July 
1995 proposal regarding label declaration of FD&C Yellow No. 6 should 
be identified with both docket numbers found in brackets in the heading 
of this document; comments on other aspects of this proposal should be 
identified with docket number 79N-0043 only. Received comments may be 
seen in the office above between 9 a.m. and 4 p.m., Monday through 
Friday.
    In addition, interested persons may, on or before June 3, 1996, 
submit to the Office of Cosmetics and Colors (address above) written 
comments containing process information relating to the identity and 
current use of substrata (including rosin) in lakes, and samples of 
such substrata. Written comments regarding the use of anions other than 
chloride and sulfate in precipitants may also be submitted to this 
address. Two copies of each comment and one 5-pound sample are to be 
submitted, and each submission is to be identified with the docket 
number (79N-0043) found in 

[[Page 8407]]
brackets in the heading of this document.

XIII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Kubo, Y., T. Iijima, ``Dye Elution from Aluminum Lake 
Synthetic Food Colors (VI) Brilliant Blue FCF Lakes,'' Shikisai, 
60(1): 2-13, 1987.
    2. Kubo, Y., M. Shirai, T. Iijima, ``Dye Elution from Aluminum 
Lake Synthetic Food Colors (VII) Lakes Produced by One-Step 
Method,'' Shikisai, 60(2):83-93, 1987.
    3. Kubo, Y., H. Kawaguchi, ``Dye Elution from Aluminum Lake 
Synthetic Food Colors (V) Indigo Carmine Lakes,'' Shikisai, 
59(11):663-669, 1986.
    4. U.S. Patent 2,418,416 to Locke, R. C., Salem, NJ assignor to 
E.I. du Pont de Nemours and Co., Wilmington, DE, ``Manufacture of 
Azo Lakes,'' April 1, 1947.
    5. U.S. Patent 2,478,768 to Locke, R. C., Salem, NJ assignor to 
E.I. du Pont de Nemours and Co., Wilmington, DE, ``Manufacture of 
Azo Lakes,'' August 9, 1949.
    6. Clark, G. R., ``Report on Pure Dye, Impurities, and Substrata 
in Pigments,'' Journal of the Association of Official Agricultural 
Chemists, 28(4):938-941, 1942.
    7. Clark, G. R., ``Report on Lakes and Pigments,'' Journal of 
the Association of Official Agricultural Chemists, 24(4):904-906, 
1941.
    8. Holtzman, H., ``The Hydrous Oxides of Aluminum and Color Lake 
Formation,'' agency internal progress report, 1942.
    9. Zuckerman, S., ``Color in Cosmetics: Cosmetics, Science and 
Technology,'' edited by E. Sagarin, Interscience Publishers, New 
York, NY, pp. 539-572, 1974.
    10. United States Department of Agriculture, Food Inspection 
Decision 76, July 13, 1907.
    11. United States Department of Agriculture, ``Certification of 
Coal-Tar Colors Begun by Food and Drug Administration,'' information 
for the press, May 11, 1939.
    12. Faulkner, E. B., ``Coping with International Color 
Regulations,'' Cosmetics & Toiletries, 107:45-49, 1992.
    13. Memorandum dated June 27, 1988, from the Additives 
Evaluation Branch, FDA, to the Division of Food and Color Additives, 
FDA.
    14. Memoranda dated July 13, 1994, and August 22, 1994, from 
Research Chemist, Office of Cosmetics and Colors, FDA (HFS- 128), to 
Aydin Orstan, FDA (HFS-217).
    15. Memorandum dated December 3, 1986, from the Division of Food 
and Color Additives, FDA, to the Division of Colors and Cosmetics, 
FDA.
    16. Color Index, 3d ed., vol. 4, Society of Dyers and 
Colourists, Bradford, Yorkshire, England, pp. 4003, 4009-4011, 4013, 
4379, 4417, 4435, 4593-4594, 1971.
    17. Marmion, D. M., Handbook of U.S. Colorants for Foods, Drugs, 
and Cosmetics, 2d ed., John Wiley and Sons, New York, NY, pp. 48, 
64-89, 1984.
    18. Food and Drug Administration, ``Report on the Certification 
of Color Additives, Foreign and Domestic Manufacturers, fiscal year 
1995.''
    19. Color Additive Master File No. 9, entry nos. 550, 550A, and 
550-addendum 1, dated September 3, 1986, October 8, 1986, and June 
3, 1987.
    20. Memoranda from the Division of Colors and Cosmetics, FDA, to 
the Division of Food and Color Additives, FDA, dated October 2, 
1986, November 21, 1986, and October 7, 1987.
    21. Food and Drug Administration, Office of Cosmetics and 
Colors, ``Intermediates and Subsidiary Colors in FD&C Blue No. 2 
Straight Color and Lake,'' September 14, 1995.
    22. Lykens, D. N., ``Thermal Stability of FD&C Lake Pigments,'' 
Plastics Compounding, pp. 35 to 40, November/December, 1986.
    23. Memorandum from the Food and Color Additives Review Section, 
FDA, to the Direct Additives Branch, FDA, dated March 19, 1991.
    24. Memorandum from the Additives Evaluation Branch, FDA, to the 
Direct Additives Branch, FDA, dated April 17, 1991.
    25. Committee on GRAS List Survey-- Phase III, ``The 1977 Survey 
of Industry on the Use of Food Additives,'' vol. 1, National Academy 
of Sciences, Washington, DC, pp. 1175 to 1192, 1979.
    26. King, J., ``Method for Determination of Color Stability in 
Laking; The Results of Experiments with the Method of Establishing 
the Stability of Color in Laking for FD&C Red No. 4 and D&C Orange 
No. 4,'' January 28, 1980.
    27. Food and Drug Administration, ``Report of FY-95 
Certification Results for Batches of D&C Lakes of D&C Orange No. 5, 
D&C Red Nos. 21, 22, 27 and 28,'' December 1, 1995.
    28. Food and Drug Administration, ``Report of FY-95 
Certification Results for Batches of D&C Yellow No. 10 Lakes 
Prepared from Certified Batches of Straight Color,'' December 1, 
1995.
    29. The Cosmetic, Toiletry, and Fragrance Association, edited by 
Wenninger, J. A., and G. N. McEwen, ``International Cosmetic 
Ingredient Dictionary, 5th ed.,'', vol. 1, Washington, DC, p. 640, 
1993.
    30. Hercules, Product Data Sheet no. 7248, for Dresinate Dry 
Powder Soaps.

List of Subjects

21 CFR Part 70

    Color additives, Cosmetics, Drugs, Labeling, Packaging and 
containers.

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

21 CFR Part 74

    Color additives, Cosmetics, Drugs, Incorporation by reference.

21 CFR Part 80

    Color additives, Cosmetics, Drugs, Reporting and recordkeeping 
requirements.

21 CFR Part 81

    Color additives, Cosmetics, Drugs.

21 CFR Part 82

    Color additives, Cosmetics, Drugs.

21 CFR Part 101

    Food Labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 178

    Food additives, Food packaging.

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 701

    Cosmetics, Labeling, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
transitional provisions of the Color Additive Amendments of 1960, and 
under authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Associate Commissioner for Regulatory Affairs, it is 
proposed that 21 CFR parts 70, 73, 74, 80, 81, 82, 101, 178, 201 and 
701 be amended as follows:

PART 70--COLOR ADDITIVES

    1. The authority citation for 21 CFR part 70 continues to read as 
follows:

    Authority: Secs. 201, 401, 402, 403, 409, 501, 512, 601, 701, 
721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 
342, 343, 348, 351, 360b, 361, 371, 379e).

    2. Section 70.3 is amended by revising paragraphs (j), (k), (l), 
and (n), and by adding new paragraphs (w) and (x) to read as follows:


Sec. 70.3  Definitions.

* * * * *
    (j) The term straight color means a color additive listed in parts 
73 or 74 of this chapter, but does not include color additive mixtures 
or lakes.
    (k) The term mixture means a color additive made by mixing two or 
more listed colors, or one or more listed colors and one or more 
diluents, without an accompanying chemical reaction.
    (l) The term lake means a color additive made by extending one or 
more straight colors on one or more substrata by adsorption, 
coprecipitation, or chemical combination, but does not include 
mixtures.
* * * * *
    (n) The term substratum means the substance on which the straight 
color in a lake is extended.
* * * * * 

[[Page 8408]]

    (w) The term listed color means a color additive listed in parts 73 
or 74 of this chapter and includes lakes.
    (x) The term repack means all or a portion of a batch of certified 
color additive that has been sealed in accordance with Sec. 70.20 and 
labeled in accordance with Sec. 70.25, but has been reopened solely for 
repackaging without further processing, or relabeled for shipment or 
delivery, by a person other than the person to whom the certificate or 
acceptance of a notice claiming certification was issued.
    3. Section 70.20 is amended by revising the section heading and 
first sentence to read as follows:


Sec. 70.20  Packaging requirements for listed colors and mixtures 
(other than hair dyes).

    Listed colors and mixtures shall be packaged in containers which 
prevent changes in composition. * * *
* * * * *
    4. Section 70.25 is amended in paragraph (a), introductory text, by 
removing from the first sentence ``80, and 81'' and adding in its place 
``and 80''; in paragraph (a)(1) by removing the words ``straight 
color'' and adding in their place the words ``listed color''; in 
paragraph (a)(3) by removing the words ``straight color'' and adding in 
their place the words ``listed color'' the two times they appear and by 
adding a new sentence at the end of the paragraph; and by revising 
paragraph (d) to read as follows:


Sec. 70.25  Labeling requirements for color additives (other than hair 
dyes).

    (a) * * *
    (3) * * * The amount of such straight color in a lake shall be 
considered part of the total amount of such straight color.
* * * * *
    (d) Special labeling for color additives not exempt from 
certification. (1) Color additives subject to the certification 
procedures of Sec. 80.31(a) of this chapter shall in addition include 
in the labeling the lot number assigned by the Color Certification 
Branch, Center for Food Safety and Applied Nutrition (CFSAN), Food and 
Drug Administration, except that in the case of any mixture for 
household use which contains not more than 15 percent of pure color and 
which is in packages containing not more than 3 ounces there appears on 
the label, a code number which the manufacturer has identified with the 
lot number by giving to the Food and Drug Administration written notice 
that such code number will be used in lieu of the lot number.
    (2) Lakes subject to the certification procedures of Sec. 80.31(b) 
of this chapter shall in addition include in the labeling:
    (i) The total color content of the lake;
    (ii) The amount of color contributed by each straight-color 
component of the lake; and
    (iii) The FDA acceptance number assigned to the firm's notice 
claiming certification for the batch.

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

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

    Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601, 
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e).


Sec. 73.1  [Amended]

    6. Section 73.1 Diluents in color additive mixtures for food use 
exempt from certification is amended in the introductory text by 
removing the words ``straight color'' and adding in their place the 
words ``listed color''.
    7. Section 73.1001 is amended in the first sentence of the 
introductory text by removing the words ``straight color'' and adding 
in their place the words ``listed color'', and in the table in 
paragraph (a)(1) by alphabetically adding four new entries to read as 
follows:


Sec. 73.1001  Diluents in color additive mixtures for drug use exempt 
from certification.

* * * * *
    (a) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
           Substances                   Definitions and specifications                   Restrictions           
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
Aluminum benzoate..............  As set forth in Sec.  74.1050(a)(3)(ii) of   ..................................
                                  this chapter.                                                                 
Barium sulfate.................  As set forth in Sec.  74.1050(a)(3)(iii) of  ..................................
                                  this chapter.                                                                 
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
Kaolin.........................  As set forth in Sec.  74.1050(a)(3)(v) of    ..................................
                                  this chapter.                                                                 
*                  *                  *                  *                  *                  *                
                                                        *                                                       
Rosin..........................  As set forth in Sec.  74.1050(a)(3)(vi) of   For use only in ingested drugs.   
                                  this chapter.                                                                 
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
----------------------------------------------------------------------------------------------------------------

*  *  *  *  *

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

    8. The authority citation for 21 CFR part 74 continues to read as 
follows:

    Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601, 
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act.

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

    9. Section 74.50 is added to subpart A to read as follows:


Sec. 74.50  Lakes for use in foods.

    (a) Identity. (1) Lakes listed in this section are color additives 
made by extending one or more certified batches of one or more straight 
colors listed in paragraph (a)(2) of this section on a substratum of 
alumina that conforms to the requirements of paragraph (a)(3) of this 
section using one or more precipitants that form aluminum (Al+3) 
cation and chloride (Cl-1) or sulfate (SO4-2) anion.
    (2) Lakes listed in this section may contain one or more of the 
following straight colors:
    (i) FD&C Blue No. 1;
    (ii) FD&C Blue No. 2;
    (iii) FD&C Green No. 3;
    (iv) FD&C Red No. 40;
    (v) FD&C Yellow No. 5; and
    (vi) FD&C Yellow No. 6.
    (3) Lakes listed in this section shall contain the substratum 
alumina, which may either conform to the requirements for alumina under 
Sec. 73.1010(a)(1) and (b) of this chapter, or may be a suspension in 
water of precipitated aluminum hydroxide that is formed from aluminum 
sulfate that meets the requirements of the Food Chemicals 

[[Page 8409]]
Codex, 2d. ed., 1972, pp. 39-40, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and sodium carbonate 
or sodium hydroxide that meets the specifications of the Food Chemicals 
Codex, 3d. ed., 1981, p. 280 (sodium carbonate) or p. 287 (sodium 
hydroxide), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, 
DC, or at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (4) Color additive mixtures for food use (including dietary 
supplements) made with lakes listed in this section may contain only 
those diluents that are suitable and that are listed in part 73 of this 
chapter as safe for use in color additive mixtures for coloring foods. 
Such mixtures shall be used in accordance with paragraph (c) of this 
section.
    (b) Specifications. Lakes listed in this section shall conform to 
the following specifications and shall be free from impurities other 
than those named, to the extent that such other impurities may be 
avoided by current good manufacturing practice:
    (1) Lead (as Pb), not more than 10 parts per million;
    (2) Arsenic (as As), not more than 3 parts per million; and
    (3) Mercury (as Hg), not more than 1 part per million.
    (c) Uses and restrictions. Lakes listed in this section may be 
safely used for coloring foods generally (including dietary 
supplements) in amounts consistent with current good manufacturing 
practice, except that:
    (1) They may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless 
added color is authorized by such standards; and
    (2) Any restriction on the use of a straight color shall also apply 
to the use of a lake of such straight color. If a lake is prepared 
using a single straight color, the lake may be used in the same manner 
as permitted for the straight color. If a lake is prepared using more 
than one straight color, its use shall be restricted to those uses 
common to all of the component straight colors.
    (d) Identification. Each lake made as prescribed in paragraph (a) 
of this section shall be considered to be a listed color and to be 
listed therein under the name that is formed as follows:
    (1) The listed names of the straight colors present in the lake (in 
descending order of predominance);
    (2) The name of the cation precipitant ``Aluminum,'' followed by 
the words ``Lake on Alumina.'' (For example, the name of a lake 
prepared by the extension of FD&C Yellow No. 5 and FD&C Blue No. 1 on 
alumina using aluminum chloride as a precipitant is ``FD&C Yellow No. 5 
and FD&C Blue No. 1 Aluminum Lake on Alumina.'')
    (e) Labeling. (1) The label of each lake listed in this section and 
any mixtures prepared from them that are intended solely or in part for 
coloring purposes shall conform to the requirements of Sec. 70.25 of 
this chapter.
    (2) Foods for human use that contain lakes listed in this section 
shall declare the presence of such lakes in accordance with 
Sec. 101.22(k)(1) of this chapter.
    (3) Butter, cheese, and cream that contain a lake of FD&C Yellow 
No. 5 or FD&C Yellow No. 6 shall be labeled in accordance with 
Sec. 101.22(k)(1) of this chapter.
    (f) Certification. All batches of lakes listed in this section 
shall be certified in accordance with regulations in part 80 of this 
chapter.
    10. Section 74.101 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.101  FD&C Blue No. 1.

    (a) * * *
    (3) Lakes made with FD&C Blue No. 1 shall conform to the 
requirements of Sec. 74.50.
*  *  *  *  *
    11. Section 74.102 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.102  FD&C Blue No. 2.

    (a) * * *
    (3) Lakes made with FD&C Blue No. 2 shall conform to the 
requirements of Sec. 74.50.
*  *  *  *  *
    12. Section 74.203 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.203  FD&C Green No. 3.

    (a) * * *
    (3) Lakes made with FD&C Green No. 3 shall conform to the 
requirements of Sec. 74.50.
* * * * *
    13. Section 74.340 is amended by revising paragraph (a)(3); in 
paragraph (d) by removing the words ``lakes or''; and in paragraph (e) 
by removing the words ``and lakes thereof'', to read as follows:


Sec. 74.340  FD&C Red No. 40.

    (a) * * *
    (3) Lakes made with FD&C Red No. 40 shall conform to the 
requirements of Sec. 74.50.
* * * * *
    14. Section 74.705 is amended by revising paragraph (a)(3) to read 
as follows:


Sec. 74.705  FD&C Yellow No. 5.

    (a) * * *
    (3) Lakes made with FD&C Yellow No. 5 shall conform to the 
requirements of Sec. 74.50.
* * * * *
    15. Section 74.706 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.706  FD&C Yellow No. 6.

    (a) * * *
    (3) Lakes made with FD&C Yellow No. 6 shall conform to the 
requirements of Sec. 74.50.
* * * * *
    16. Section 74.1050 is added to subpart B to read as follows:


Sec. 74.1050  Lakes for use in drugs.

    (a) Identity. (1) Lakes listed in this section are color additives 
made by extending one or more certified batches of one or more straight 
colors specified in paragraph (a)(2) of this section on one or more 
substrata specified in paragraph (a)(3) of this section, using one or 
more precipitants that form aluminum (Al+3), barium (Ba+2), 
calcium (Ca+2), potassium (K+1), sodium (Na+1), 
strontium (Sr+2), or zirconium (Zr+4) cation, and chloride 
(Cl-1) or sulfate (SO4-2) anion.
    (2) Lakes listed in this section may contain one or more of the 
following straight colors:
    (i) FD&C Blue No. 1;
    (ii) FD&C Blue No. 2;
    (iii) FD&C Green No. 3;
    (iv) FD&C Yellow No. 5;
    (v) FD&C Yellow No. 6;
    (vi) FD&C Red No. 4;
    (vii) FD&C Red No. 40;
    (viii) D&C Blue No. 4;
    (ix) D&C Orange No. 4;
    (x) D&C Orange No. 5;
    (xi) D&C Orange No. 10;
    (xii) D&C Red No. 6;
    (xiii) D&C Red No. 7;
    (xiv) D&C Red No. 21;
    (xv) D&C Red No. 22;
    (xvi) D&C Red No. 27;
    (xvii) D&C Red No. 28;
    (xviii) D&C Red No. 31;
    (xix) D&C Red No. 33;
    (xx) D&C Red No. 34; and
    (xxi) D&C Yellow No. 10.
    (3) Lakes listed in this section may contain one or more of the 
following substrata: 

[[Page 8410]]

    (i) Alumina that conforms to the requirements of Sec. 74.50(a)(3) 
of this chapter; and
    (ii) Aluminum benzoate that is prepared from aluminum chloride or 
aluminum sulfate that conforms to the requirements of the United States 
Pharmacopeia, 23d ed. (1995), p. 64 (aluminum chloride) or p. 68 
(aluminum sulfate), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, and benzoic acid that conforms 
to the requirements of the United States Pharmacopeia, 23d ed. (1995), 
pp. 176 and 177, which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the United 
States Pharmacopoeial Convention, Inc., 12601 Twinbrook Pkwy., 
Rockville, MD 20852, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, 
DC, or at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (iii) Barium sulfate that conforms to the requirements of the 
United States Pharmacopeia, 23d ed. (1995), pp. 165 and 166, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (a)(3)(ii) of this section.
    (iv) Calcium carbonate that conforms to the requirements of 
Sec. 73.1070(a)(1) and (b) of this chapter.
    (v) Kaolin that conforms to the requirements of the United States 
Pharmacopeia, 23d ed. (1995), p. 863, which are incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The 
availability of this incorporation by reference is given in paragraph 
(a)(3)(ii) of this section.
    (vi) Rosin, which is the pale, cream-colored sodium soap of the 
residue left after distilling off the volatile oil from the oleoresin 
obtained from Pinus palustris and other species of Pinus, and which 
conforms to the following specifications:
    (A) Solids, not less than 95 percent;
    (B) Acid number, not greater than 7.5; and
    (C) Free alkali, not greater than 2.5 percent.
    (vii) Talc that conforms to the requirements of Sec. 73.1550(a)(1) 
and (b) of this chapter.
    (viii) Titanium dioxide that conforms to the requirements of 
Sec. 73.575 (a)(1) and (b) of this chapter.
    (ix) Zinc oxide that conforms to the requirements of 
Sec. 73.1991(a)(1) and (b) of this chapter.
    (4) Color additive mixtures for drug use made with lakes listed in 
this section may contain only those diluents that are suitable and that 
are listed in part 73 of this chapter as safe for use in color additive 
mixtures for coloring drugs. Such mixtures shall be used in accordance 
with paragraph (c) of this section.
    (b) Specifications. Lakes listed in this section shall conform to 
the following specifications and shall be free from impurities other 
than those named, to the extent that such other impurities may be 
avoided by current good manufacturing practice:
    (1) Lead (as Pb), not more than 20 parts per million;
    (2) Arsenic (as As), not more than 3 parts per million;
    (3) Mercury (as Hg), not more than 1 part per million; and
    (4) For a lake that contains a barium salt, soluble barium (in 
dilute HCl) as BaCl2, not more than 0.05 percent.
    (c) Uses and restrictions. Lakes listed in this section may be 
safely used for coloring drugs generally in amounts consistent with 
current good manufacturing practice, except that:
    (1) Any restriction on the use of a straight color shall also apply 
to the use of a lake of such straight color. If a lake is prepared 
using a single straight color, the lake may be used in the same manner 
as permitted for the straight color. If a lake is prepared using more 
than one straight color, its use shall be restricted to those uses 
common to all of the component straight colors. (For example, a lake 
produced using two straight colors, one listed for use in coloring 
drugs generally and one listed for use in coloring externally applied 
drugs only, may be used only for coloring externally applied drugs.)
    (2) Where regulations impose quantitative limitations for a general 
or specific use of a straight color, the amount of such straight color 
in a lake shall be considered part of the total amount of such straight 
color in a drug product.
    (3) The aluminum lakes on alumina of FD&C Blue No. 1, FD&C Red No. 
40, and FD&C Yellow No. 5, prepared in accordance with the requirements 
of Sec. 74.50, may be safely used for coloring drugs intended for use 
in the area of the eye, in amounts consistent with current good 
manufacturing practice. Use of these lakes in the area of the eye is 
subject to the limitations in Sec. 70.5 (b) and (c) of this chapter and 
does not include use in articles intended for use in injections or as a 
surgical suture in the area of the eye.
    (d) Identification. Each lake made as prescribed in paragraph (a) 
of this section shall be considered to be a listed color and to be 
listed therein under the name that is formed as follows:
    (1) The listed names of the straight colors present in the lake (in 
descending order of predominance);
    (2) The names of the cations of the precipitants, followed by the 
words ``Lake on ______'';
    (3) The names of the substrata (in descending order of 
predominance). (For example: The name of a lake prepared by the 
extension of FD&C Red No. 40 and D&C Orange No. 5 on alumina and 
titanium dioxide using aluminum chloride and calcium chloride as 
precipitants is ``FD&C Red No. 40 and D&C Orange No. 5 Aluminum/Calcium 
Lake on Alumina and Titanium Dioxide.'')
    (e) Labeling. (1) The label of each lake listed in this section and 
any mixtures prepared from them that are intended solely or in part for 
coloring purposes shall conform to the requirements of Sec. 70.25 of 
this chapter.
    (2) Drugs that contain a lake of FD&C Yellow No. 5 shall be labeled 
in accordance with Sec. 74.1705 (c)(2) and (c)(3).
    (3) Drugs that contain a lake of FD&C Yellow No. 6 shall be labeled 
in accordance with Sec. 74.1706(c)(2).
    (f) Certification. All batches of lakes listed in this section 
shall be certified in accordance with regulations in part 80 of this 
chapter.
    17. Section 74.1101 is amended by adding a new paragraph (a)(4), by 
removing paragraphs (b)(2) and (c)(2) and redesignating paragraph 
(b)(1) and (c)(1) as paragraphs (b) and (c), respectively, to read as 
follows:


Sec. 74.1101  FD&C Blue No. 1.

    (a) * * *
    (4) Lakes made with FD&C Blue No. 1 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    18. Section 74.1102 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1102  FD&C Blue No. 2.

    (a) * * *
    (3) Lakes made with FD&C Blue No. 2 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    19. Section 74.1104 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1104  FD&C Blue No. 4.

    (a) * * *
    (3) Lakes made with FD&C Blue No. 4 shall conform to the 
requirements of Sec. 74.1050.
* * * * * 

[[Page 8411]]

    20. Section 74.1203 is amended by adding a new paragraph (a)(3) to 
read as follows:


Sec. 74.1203  FD&C Green No. 3.

    (a) * * *
    (3) Lakes made with FD&C Green No. 3 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    21. Section 74.1254 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1254  D&C Orange No. 4.

    (a) * * *
    (3) Lakes made with D&C Orange No. 4 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    22. Section 74.1255 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1255  D&C Orange No. 5.

    (a) * * *
    (3) Lakes made with D&C Orange No. 5 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    23. Section 74.1260 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1260  D&C Orange No. 10.

    (a) * * *
    (3) Lakes made with D&C Orange No. 10 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    24. Section 74.1304 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1304  FD&C Red No. 4.

    (a) * * *
    (3) Lakes made with FD&C Red No. 4 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    25. Section 74.1306 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1306  D&C Red No. 6.

    (a) * * *
    (3) Lakes made with D&C Red No. 6 shall conform to the requirements 
of Sec. 74.1050.
* * * * *
    26. Section 74.1307 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1307  D&C Red No. 7.

    (a) * * *
    (3) Lakes made with D&C Red No. 7 shall conform to the requirements 
of Sec. 74.1050.
* * * * *
    27. Section 74.1321 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1321  D&C Red No. 21.

    (a) * * *
    (3) Lakes made with D&C Red No. 21 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    28. Section 74.1322 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1322  D&C Red No. 22.

    (a) * * *
    (3) Lakes made with D&C Red No. 22 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    29. Section 74.1327 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1327  D&C Red No. 27.

    (a) * * *
    (3) Lakes made with D&C Red No. 27 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    30. Section 74.1328 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1328  D&C Red No. 28.

    (a) * * *
    (3) Lakes made with D&C Red No. 28 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    31. Section 74.1331 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1331  D&C Red No. 31.

    (a) * * *
    (3) Lakes made with D&C Red No. 31 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    32. Section 74.1333 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1333  D&C Red No. 33.

    (a) * * *
    (3) Lakes made with D&C Red No. 33 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    33. Section 74.1334 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1334  D&C Red No. 34.

    (a) * * *
    (3) Lakes made with D&C Red No. 34 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    34. Section 74.1340 is amended by revising paragraph (a)(3); by 
removing paragraph (b)(2); by redesignating paragraph (b)(1) as 
paragraph (b); by amending newly redesignated paragraph (b) by removing 
the phrase ``and FD&C Red No. 40 Aluminum Lake''; by amending paragraph 
(c) by removing the phrase ``lakes or''; and by amending paragraph (d) 
by removing the phrase ``and lakes thereof'' to read as follows:


Sec. 74.1340  FD&C Red No. 40.

    (a) * * *
    (3) Lakes made with FD&C Red No. 40 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    35. Section 74.1705 is amended by revising paragraph (a)(2); by 
removing paragraph (b)(2); by redesignating paragraph (b)(1) as 
paragraph (b); and by removing in the first sentence of paragraph 
(c)(2) and paragraph (c)(3), the phrase ``containing FD&C Yellow No. 
5'' and adding in its place the phrase ``containing FD&C Yellow No. 5 
or a lake of FD&C Yellow No. 5''.


Sec. 74.1705  FD&C Yellow No. 5.

    (a) * * *
    (2) Lakes made with FD&C Yellow No. 5 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    36-37. Section 74.1706 is amended by adding new paragraphs (a)(3) 
and (c)(2) to read as follows:


Sec. 74.1706  FD&C Yellow No. 6.

    (a) * * *
    (3) Lakes made with FD&C Yellow No. 6 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    (c) * * *
    (2) The label of over-the-counter and prescription drug products 
intended for human use and administered orally, nasally, rectally, or 
vaginally containing FD&C Yellow No. 6, or a lake of FD&C Yellow No. 6, 
shall specifically declare the presence of FD&C Yellow No. 6 by listing 
the color additive using the name FD&C Yellow No. 6. The labels of 
certain drug products subject to this labeling requirement that are 
also cosmetics, such as antibacterial mouthwashes and fluoride 
toothpastes, need not comply with this requirement provided they comply 
with the requirements of Sec. 701.3 of this chapter.
    38. Section 74.1710 is amended by adding new paragraph (a)(3) to 
read as follows:


Sec. 74.1710  D&C Yellow No. 10.

    (a) * * * 
    
[[Page 8412]]

    (3) Lakes made with D&C Yellow No. 10 shall conform to the 
requirements of Sec. 74.1050.
* * * * *
    39. Section 74.2050 is added to subpart C to read as follows:


Sec. 74.2050  Lakes for use in cosmetics.

    (a) Identity and specifications. Lakes listed in this section shall 
conform in identity and specifications to the requirements of 
Sec. 74.1050(a)(1), (a)(2), (a)(3), and (b), except that the straight 
color FD&C Blue No. 2 shall not be a component of such lakes.
    (b) Uses and restrictions. Lakes listed in this section may be 
safely used for coloring cosmetics generally in amounts consistent with 
current good manufacturing practice, except that:
    (1) Any restriction on the use of a straight color shall also apply 
to the use of a lake of such straight color. If a lake is prepared 
using a single straight color, the lake may be used in the same manner 
as permitted for the straight color. If a lake is prepared using more 
than one straight color, its use shall be restricted to those uses 
common to all of the component straight colors. (For example, a lake 
produced using two straight colors, one listed for use in coloring 
cosmetics generally and one listed for use in coloring externally 
applied cosmetics only, may be used only for coloring externally 
applied cosmetics.)
    (2) Where regulations impose quantitative limitations for a general 
or specific use of a straight color, the amount of such straight color 
in a lake shall be considered a part of the total amount of such 
straight color in a cosmetic product.
    (3) The aluminum lakes on alumina of FD&C Blue No. 1, FD&C Red No. 
40, and FD&C Yellow No. 5, prepared in accordance with the requirements 
of Sec. 74.50, may be safely used for coloring cosmetics intended for 
use in the area of the eye, in amounts consistent with current good 
manufacturing practice. Use of these lakes in the area of the eye is 
subject to the limitations in Sec. 70.5(b) and (c) of this chapter, and 
does not include use in articles intended for use in injections or as a 
surgical suture in the area of the eye.
    (c) Identification. Each lake made as prescribed in paragraph (a) 
of this section shall be considered to be a listed color and to be 
listed therein under the name that is formed as prescribed in 
Sec. 74.1050(d).
    (d) Labeling. (1) The label of each lake listed in this section and 
any mixtures prepared from that are intended solely or in part for 
coloring purposes shall conform to the requirements of Sec. 70.25 of 
this chapter.
    (2) Cosmetics that contain lakes listed in this section shall 
declare the presence of such lakes in accordance with 
Sec. 701.3(c)(1)(i) of this chapter.
    (e) Certification. All batches of lakes listed in this section 
shall be certified in accordance with regulations in part 80 of this 
chapter.
    40. Section 74.2101 is amended by removing paragraphs (b)(2) and 
(c)(2); by redesignating paragraphs (a), (b)(1), and (c)(1) as 
paragraphs (a)(1), (b), and (c), respectively; and by adding new 
paragraph (a)(2) to read as follows:


Sec. 74.2101  FD&C Blue No. 1.

    (a) * * *
    (2) Lakes made with FD&C Blue No. 1 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    41. Section 74.2104 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2104  D&C Blue No. 4.

    (a) * * *
    (2) Lakes made with D&C Blue No. 4 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    42. Section 74.2203 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2203  FD&C Green No. 3.

    (a) * * *
    (2) Lakes made with FD&C Green No. 3 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    43. Section 74.2254 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2254  D&C Orange No. 4.

    (a) * * *
    (2) Lakes made with D&C Orange No. 4 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    44. Section 74.2255 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2255  D&C Orange No. 5.

    (a) * * *
    (2) Lakes made with D&C Orange No. 5 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    45. Section 74.2260 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and adding new paragraph (a)(2) to read as follows:


Sec. 74.2260  D&C Orange No. 10.

    (a) * * *
    (2) Lakes made with D&C Orange No. 10 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    46. Section 74.2304 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2304  FD&C Red No. 4.

    (a) * * *
    (2) Lakes made with FD&C Red No. 4 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    47. Section 74.2306 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2306  D&C Red No. 6.

    (a) * * *
    (2) Lakes made with D&C Red No. 6 shall conform to the requirements 
of Sec. 74.2050.
* * * * *
    48. Section 74.2307 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2307  D&C Red No. 7.

    (a) * * *
    (2) Lakes made with D&C Red No. 7 shall conform to the requirements 
of Sec. 74.2050.
* * * * *
    49. Section 74.2321 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2321  D&C Red No. 21.

    (a) * * *
    (2) Lakes made with D&C Red No. 21 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    50. Section 74.2322 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2322  D&C Red No. 22.

    (a) * * *
    (2) Lakes made with D&C Red No. 22 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    51. Section 74.2327 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows: 


[[Page 8413]]



Sec. 74.2327  D&C Red No. 27.

    (a) * * *
    (2) Lakes made with D&C Red No. 27 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    52. Section 74.2328 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2328  D&C Red No. 28.

    (a) * * *
    (2) Lakes made with D&C Red No. 28 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    53. Section 74.2331 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2331  D&C Red No. 31.

    (a) * * *
    (2) Lakes made with D&C Red No. 31 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    54. Section 74.2333 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2333  D&C Red No. 33.

    (a) * * *
    (2) Lakes made with D&C Red No. 33 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    55. Section 74.2334 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2334  D&C Red No. 34.

    (a) * * *
    (2) Lakes made with D&C Red No. 34 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    56. Section 74.2340 is amended by revising paragraph (a)(2); by 
removing in the introductory text of paragraph (b) the phrase ``except 
that only FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be 
safely used in coloring'' and adding in its place the word 
``including'', in paragaph (b)(2) by removing the words ``additives'' 
and ``their'' and adding in their place the words ``additive'' and 
``its'', respectively, to read as follows:


Sec. 74.2340  FD&C Red No. 40.

    (a) * * *
    (2) Lakes made with FD&C Red No. 40 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    57. Section 74.2705 is amended by redesignating paragraph (a) as 
paragraph (a)(1) and by adding new paragraph (a)(2), by removing 
paragraph (b)(2) and (c)(2) and redesignating paragraphs (b)(1) and 
(c)(1) as paragraphs (b) and (c), respectively, to read as follows:


Sec. 74.2705  FD&C Yellow No. 5.

    (a) * * *
    (2) Lakes made with FD&C Yellow No. 5 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    58-59. Section 74.2706 is amended by redesignating paragraph (a) as 
paragraph(a)(1) and by adding new paragraph (a)(2) to read as follows:


Sec. 74.2706  FD&C Yellow No. 6.

    (a) * * *
    (2) Lakes made with FD&C Yellow No. 6 shall conform to the 
requirements of Sec. 74.2050.
* * * * *
    60. Section 74.2710 is amended by redesignating paragraph (a) as 
paragraph(a)(1) and by adding a new paragraph (a)(2) to read as 
follows:


Sec. 74.2710  D&C Yellow No. 10.

    (a) * * *
    (2) Lakes made with D&C Yellow No. 10 shall conform to the 
requirements of Sec. 74.2050.
* * * * *

PART 80--COLOR ADDITIVE CERTIFICATION

    61. The authority citation for 21 CFR Part 80 continues to read as 
follows:

    Authority: Secs. 701, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371, 379e).

    62. Section 80.10 is amended in paragraph (a) by revising the 
paragraph heading and by removing the phrase ``and (j)(2)''; in 
paragraph (b), introductory text, by revising the paragraph heading and 
by removing ``Sec. 80.21(j)(3) and (j)(4)'' and adding in its place 
``Sec. 80.21(j)(2) and (j)(3)''; by redesignating paragraphs (c), (d), 
(e), and (f) as paragraphs (d), (e), (f), and (g), respectively, by 
amending newly redesignated paragraph (d) by removing the phrase ``(a) 
and (b)'' and adding in its place the phrase ``(a), (b), and (c)'', and 
by adding new paragraph (c) to read as follows:


Sec. 80.10  Fees for certification services.

    (a) Fees for straight colors. * * *
* * * * *
    (b) Fees for repacks of certified straight colors and color 
additive mixtures. * * *
* * * * *
    (c) Fees for lakes and repacks of certified lakes. The fee for the 
services provided under the regulations in this part in the case of 
each notice claiming certification submitted in accordance with 
Sec. 80.33 shall be $30.00.
* * * * *
    63. Section 80.21 is amended in paragraph (g)(1) by removing the 
phrase ``and lakes''; by amending paragraph (g)(2) by adding the words 
``of straight colors'' at the end of the sentence; by revising 
paragraph (h)(1); by removing paragraph (h)(2) and redesignating 
paragraphs (h)(3) and (h)(4) as paragraphs (h)(2) and (h)(3), 
respectively; by revising newly redesignated paragraph (h)(3); by 
amending paragraph (j), introductory text, by removing the words ``a 
lake,'' and by removing the phrase ``previously certified color 
additive'' and adding in its place the phrase ``previously certified 
straight color''; by removing paragraph (j)(2) and redesignating 
paragraphs (j)(3) and (j)(4) as paragraphs (j)(2) and (j)(3), 
respectively; and by revising the paragraph heading of newly designated 
paragraph (j)(2) to read as follows:


Sec. 80.21  Request for certification.

* * * * *
    (h) * * *
    (1) The name of a straight color shall be the name of the color 
additive as listed in part 74 of this chapter.
* * * * *
    (3) The name of a repack shall be the name described in paragraph 
(h)(1) or (h)(2) of this section, whichever is applicable.
* * * * *
    (j) * * *
    (2) Request for certification of a repack of a batch of certified 
straight color. * * *
* * * * *
    64. Section 80.22 is revised to read as follows:


Sec. 80.22  Samples to accompany requests for certification or to be 
held as records.

    (a) Straight colors and their mixtures and repacks. A sample of a 
batch of color additive which is to accompany a request for 
certification shall:
    (1) Be taken only after such batch has been so thoroughly mixed as 
to be of uniform composition throughout;
    (2) Be held under the control of the person requesting 
certification until certified; and
    (3) Be labeled to show:
    (i) The name of the color additive;
    (ii) The manufacturer's batch number;
    (iii) The quantity of such batch; 
    
[[Page 8414]]

    (iv) The name and post office address of the person requesting 
certification of such batch; and
    (v) Be accompanied by any label or labeling intended to be used.
    (b) Lakes and their repacks. A sample of a batch of lake that is to 
be held by a firm claiming certification for the batch shall:
    (1) Be taken prior to submission of the notice claiming 
certification;
    (2) Be taken only after such batch has been so thoroughly mixed as 
to be of uniform composition throughout;
    (3) Be sealed and stored in such a manner as to prevent change in 
composition;
    (4) Be held by the firm claiming certification for the batch, as 
required by Sec. 80.39(b)(3); and
    (5) Be labeled to show:
    (i) The name of the lake;
    (ii) The percent total color for the batch and, if the batch 
contains more than one straight color, the percent color in the batch 
for each straight color;
    (iii) The firm's batch number and the date the sample was taken;
    (iv) The quantity of the batch;
    (v) The name and place of business of the firm claiming 
certification for the batch;
    (vi) A copy of any label or labeling intended to be used with the 
batch; and
    (vii) After receipt of an acceptance of the notice claiming 
certification for the batch, FDA's acceptance number.
    65. Section 80.31 is amended in paragraph (a) by adding a new 
heading; by removing in paragraph (a)(2) in the phrase ``parts 81 and 
82'' and adding in its place ``part 74'', by removing in paragraph 
(a)(3) the phrase ``81, and 82'', by revising paragraph (b), and by 
adding new paragraph (c) to read as follows:


Sec. 80.31  Certification.

    (a) Straight colors and their mixtures and repacks. * * *
* * * * *
    (b) Lakes and their repacks. If the Commissioner determines, after 
such investigations as the Commissioner considers to be necessary, 
that:
    (1) A notice submitted in accordance with Sec. 80.33 appears to 
contain no untrue statement of a material fact;
    (2) Such lake conforms to the specifications and any other 
conditions set forth therefor in part 74 of this chapter;
    (3) The manufacturer of the lake is the firm that was issued the 
certificate for each batch of straight color used in the lake;
    (4) The manufacturer or repacker of the batch has complied with the 
notification requirements in Sec. 80.33 and the recordkeeping 
requirements in Sec. 80.39; and
    (5) The batch covered by such notice otherwise appears to comply 
with the regulations in this chapter, the Commissioner shall issue to 
the firm that submitted the notice, an acceptance showing the 
acceptance number assigned to such notice. Upon issuance of such an 
acceptance, the batch covered by the notice, subject to the terms, 
conditions and restrictions prescribed by part 74 of this chapter, is a 
certified batch.
    (c) If the Commissioner determines, after such investigation as the 
Commissioner considers to be necessary, that a request submitted in 
accordance with Sec. 80.21, or the batch of color additive covered by 
such request, does not comply with the requirements prescribed by 
paragraph (a) of this section for the issuance of a certificate, or 
that a notice submitted in accordance with Sec. 80.33, or the batch of 
lake covered by such notice, does not comply with the requirements 
prescribed by paragraph (b) of this section for the issuance of an 
acceptance of the notice, the Commissioner shall refuse to certify such 
batch and shall give notice thereof to the person who submitted such 
request, or such notice, stating the Commissioner's reasons for 
refusal. Any person who contests such refusal shall have an opportunity 
for a regulatory hearing before the Food and Drug Administration 
pursuant to part 16 of this chapter.
    66. Section 80.32 is amended by revising the section heading and 
paragraphs (a), (b), (c), and the introductory text of paragraph (d); 
in paragraphs (e), (f), introductory text, and (g) by adding the words 
``or an acceptance of a notice claiming certification'' after the words 
``A certificate''; and in paragraph (h) by revising the first sentence 
to read as follows:


Sec. 80.32  Limitations of certification.

    (a) If a certificate or an acceptance of a notice claiming 
certification is obtained through fraud or misrepresentation of a 
material fact, such certificate or acceptance shall not be effective, 
and a color additive from the batch on which such certificate or 
acceptance was issued, or from any batch of lake prepared with such 
color additive, shall be considered to be from a batch that has not 
been certified in accordance with the regulations in this part. 
Whenever the Commissioner learns that any certificate or acceptance of 
a notice claiming certification has been obtained through fraud or 
material misrepresentation, the Commissioner shall notify the holder of 
the certificate or acceptance that it is of no effect.
    (b) If, between the time a sample of color additive accompanying a 
request for certification or retained by a firm that has submitted a 
notice claiming certification is taken from a batch of color additive 
and the time a certificate or an acceptance of the notice claiming 
certification for such batch is received by the person to whom such 
certificate or acceptance is issued, any such color additive becomes 
changed in composition, such certificate or such acceptance shall not 
be effective with respect to such changed color additive, and such 
changed color additive, and any lake prepared with such color additive, 
shall be considered to be from a batch that has not been certified in 
accordance with the regulations in this part.
    (c) If, at any time after a certificate or an acceptance of a 
notice claiming certification is received by the person to whom it is 
issued, any color additive from the batch covered by such certificate 
or acceptance becomes changed in composition, such certificate or 
acceptance shall expire with respect to such changed color additive. 
After such expiration, such color additive and any lake prepared with 
such color additive shall be considered to be from a batch that has not 
been certified in accordance with this part; except that such color 
additive or lake shall not be so considered when used for coloring a 
food, drug, or cosmetic, or for the purpose of certifying a batch of a 
mixture in which such color additive was used as an ingredient, or for 
use in preparing a batch of a mixture for which exemption from 
certification has been authorized, or for use in preparing a batch of 
lake for which certification is claimed under Sec. 80.31(b), if such 
change resulted solely from such use.
    (d) A certificate or an acceptance of a notice claiming 
certification shall expire with respect to any color additive covered 
thereby if the package in which such color additive was closed for 
shipment or delivery is opened. After such expiration such color 
additive shall be considered to be from a batch that has not been 
certified, except that such color additive shall not be so considered 
when the package is opened;
* * * * *
    (h) When the listing or the specifications for a color additive are 
revoked or amended, the final order effecting the revocation or 
amendment may specify, in addition to its own effective date, a date on 
which all previous certificates or acceptances of

[[Page 8415]]

notices claiming certification for existing batches and portions of 
batches of such a color additive issued under the revoked or amended 
regulations shall cease to be effective; and any such lots or batches 
of the color additive, and any batches of lake prepared from such lots 
or batches, shall be regarded as uncertified after the date specified 
unless a new certificate or, for a lake, a new acceptance of a notice 
claiming certification, can be and is obtained in conformance with the 
new regulations. * * *
    67. New Sec. 80.33 is added to subpart B to read as follows:


Sec. 80.33  Notice claiming certification for a batch of lake.

    A notice claiming certification for a batch of lake or lake repack 
shall:
    (a) Be addressed to the Commissioner of Food and Drugs;
    (b) Be prepared in the manner set forth in paragraph (i) of this 
section;
    (c) Be submitted in duplicate;
    (d) Be signed by a responsible officer of the firm submitting the 
notice. In the case of a foreign company, the notice must be signed by 
a responsible officer of such firm, and by an agent of the firm who 
resides in the United States;
    (e) Show the name and place of business (street address, city, 
State, and zip code) of the firm submitting the notice;
    (f) Be accompanied by the fee prescribed in Sec. 80.10 unless the 
firm has established an advanced deposit to be used for prepayment of 
such fees. In no case shall the Commissioner consider a notice claiming 
certification for a batch of lake or lake repack if the fee 
accompanying such notice is less than that required by Sec. 80.10 or if 
such fee exceeds the amount held in the advance deposit account of the 
firm submitting such notice; and
    (g) Be accompanied by any label or labeling intended to be used 
with the batch.
    (h) The name of a lake shall be the name derived in the manner 
described in part 74 of this chapter.
    (i) The form for submission of the notice shall be one of the 
following, depending on whether the color additive is a new batch of 
lake or a repack of a previously certified batch of lake:
    (1) Notice claiming certification for a new batch of lake.
Date-------------------------------------------------------------------
Division of Programs and Enforcement Policy (HFS-105), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 
C St. SW., Washington, DC 20204.
    In accordance with the regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act, we hereby give notice that we claim 
certification for a batch of lake.
Name of lake-----------------------------------------------------------
Batch number-----------------------------------------------------------
Batch weighs-----------------------------------------------------------
  pounds (or kilograms)
Total color ______ percent of batch
For each straight color used:
Color content ______ percent of batch.
How stored pending certification---------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
(State conditions of storage, with kind and size of containers, 
location, etc.)
For use in-------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
(State proposed uses)
Ingredients of batch
Name of each straight color used---------------------------------------
----------------------------------------------------------------------
For each straight color used:
Certified Lot number---------------------------------------------------
Quantity used ______ pounds (or kilograms)
For each precipitant or substratum ingredient used:
Name of ingredient used------------------------------------------------
Quantity used ______ pounds (or kilograms)
    If any previously certified batches of lake have been used, 
provide the following information for each such batch.
Name of lake-----------------------------------------------------------
FDA acceptance number
(or certified lot number)----------------------------------------------
Quantity used----------------------------------------------------------
pounds (or kilograms), Required fee, Sec. 30.00
(drawn to the order of Food and Drug Administration.)
    This batch of lake was manufactured by the undersigned firm and 
meets the requirements of 21 CFR parts 74 and 80. The records 
required by 21 CFR 80.39, including a representative sample of the 
batch, are available for FDA inspection at the undersigned firm.
(Signed)---------------------------------------------------------------
By---------------------------------------------------------------------
(Title)
    (2) Notice claiming certification for a repack of a batch of 
certified lake.
Date-------------------------------------------------------------------
Division of Programs and Enforcement Policy (HFS-105), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 
C St. SW., Washington, DC 20204.
    In accordance with the regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act, we hereby give notice that we claim 
certification for a batch of lake repack.
Name of lake-----------------------------------------------------------
Original batch:
FDA acceptance number
(or certified lot number)----------------------------------------------
Total color ______ percent of batch
For each straight color used:
Color content ______ percent of batch.
This lake obtained from (provide name and place of business of 
manufacturer of the lake)
Batch number-----------------------------------------------------------
Batch weighs ______ pounds
(or kilograms)
Repacked batch:
Total color ______ percent of batch
For each straight color used:
Color content ______ percent of batch.
How stored pending certification---------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
(State conditions of storage, with kind and size of containers, 
location, etc.)
Certified for use in---------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
(State proposed uses)

Required fee, $30.00 (drawn to the order of Food and Drug 
Administration).
    This batch of lake was repacked by the undersigned firm and 
meets the requirements of 21 CFR parts 74 and 80. The records 
required by 21 CFR 80.39, including a representative sample of the 
batch, are available for FDA inspection at the undersigned firm.
(Signed)---------------------------------------------------------------
By---------------------------------------------------------------------

    (j) The Food and Drug Administration will furnish a response to 
each notifier within 5 working days of receipt of the notice. The 
response will either:
    (1) Accept the notice claiming certification; or
    (2) Reject the notice claiming certification, in which case the 
batch of lake covered by the notice has not complied with the 
requirements of Sec. 80.31(b) of this chapter and is not a certified 
batch.


Sec. 80.34  [Amended]

    68. Section 80.34 Authority to refuse certification service is 
amended in paragraph (a)(1) by removing the phrase ``a certificate'' 
and adding in its place the phrase ``a certificate or an acceptance of 
a notice claiming certification''; and in paragraph (a)(4) by removing 
the phrase ``color additives and intermediates'' and adding in its 
place ``color additives, intermediates and substrata''.


Sec. 80.35  [Amended]

    69. Section 80.35 Color additive mixtures; certification and 
exemption from certification is amended in paragraphs (a) and (b) by 
removing the words ``straight colors'' and adding in their place the 
words ``listed colors''; and in paragraph (b) by removing the words 
``straight color'' and adding in their place the words ``listed color'' 
the three times they appear.
    70. Section 80.37 is revised to read as follows:


Sec. 80.37  Treatment of batch pending certification.

    Immediately after the sample is taken that (for a batch of color 
additive subject to certification under Sec. 80.31(a)) is to accompany 
a request for certification of the batch or (for a batch of lake 
subject to certification under Sec. 80.31(b)) is to be 

[[Page 8416]]
retained by the firm preparing or repacking the batch, the batch shall 
be:
    (a) Stored in containers of such kind as to prevent change in 
composition.
    (b) Held under the control of the person requesting or claiming 
certification until certified.
    (c) Marked, by labeling or otherwise, in a manner such that there 
can be no question as to the identity of the batch and no question that 
it is not to be used until the requested certificate or acceptance of 
the notice claiming certification has been issued.
    71. Section 80.38 is revised to read as follows:


Sec. 80.38  Treatment of batch after certification.

    (a) Labeling. (1) Immediately upon notification that a batch of 
color additive has been certified under Sec. 80.31(a), the person 
requesting certification thereof shall identify such batch, by 
labeling, with the certified lot number.
    (2) Immediately upon notification that the notice submitted in 
accordance with Sec. 80.33 has been accepted, the firm claiming 
certification for the batch shall identify such batch, by labeling, 
with the FDA acceptance number.
    (b) Storage. The person requesting or claiming certification shall 
maintain storage in such manner as to prevent change in composition 
until such batch has been packaged and labeled as required by 
Secs. 70.20 and 70.25 of this chapter, except that the person 
requesting or claiming certification may use such color additive for 
the purpose of coloring a food, drug, or cosmetic.
    72. Section 80.39 is revised to read as follows:


Sec. 80.39  Records.

    (a) Records of distribution. (1) The person to whom a certificate 
is issued or the firm to which FDA issues an acceptance of a notice 
claiming certification shall keep complete records showing the disposal 
of all the color additive from the batch covered by such certificate or 
such acceptance. These records shall show:
    (i) Each quantity used by such person or firm from such batch and 
the date and kind of such use.
    (ii) The date and quantity of each shipment or delivery from such 
batch, and the name and post office address of the person to whom such 
shipment or delivery was made.
    (2) Upon the request of any officer or employee of the Food and 
Drug Administration or of any other officer or employee acting on 
behalf of the Secretary of Health and Human Services, such person or 
such firm, at all reasonable hours until at least 2 years after 
disposal of all such color additive, shall make the records required by 
paragraph (a)(1) of this section available to any such officer or 
employee, and shall accord to such officer or employee full opportunity 
to make inventory of stocks of such color additive on hand and 
otherwise to check the correctness of such records.
    (b) Certification records for lakes. (1) The manufacturer or 
repacker of a lake certified under Sec. 80.31(b) shall keep complete 
records showing that the batch of lake covered by the notice claiming 
certificaion is in compliance with parts 74 and 80 of this chapter.
    (i) For both manufacturers and repackers, these records shall 
include:
    (A) A copy of the notice claiming certification for the batch;
    (B) A copy of FDA's acceptance of the notice; and
    (C) Complete reports of all chemical analyses performed on the 
batch. Such analyses shall include, for each batch, analyses that 
establish the percent total color for the batch and, if the batch 
contains more than one straight color, the percent color for each 
straight color in the batch.
    (ii) For manufacturers only, the records shall also include:
    (A) A copy of the certificate for each batch of straight color used 
to prepare the batch of lake;
    (B) For each certified batch of lake that was used as an 
ingredient, a copy of FDA's acceptance of the notice claiming 
certification for the batch, or if certified before (date of 
publication of the final rule), a copy of the certificate for the 
batch;
    (C) Manufacturer specifications for substratum and precipitant 
ingredients used in the preparation of the batch; and
    (D) For each batch that contains a barium salt as provided in 
Secs. 74.1050 and 74.2050 of this chapter, analyses that show that the 
batch meets the specification for soluble barium in Sec. 74.1050(b) of 
this chapter.
    (2) A firm claiming certification for a batch of lake under 
Sec. 80.31(b) shall retain an 8-ounce sample of the batch as required 
by Sec. 80.22(b); however, such sample need not be submitted to FDA.
    (3) Upon the request of any officer or employee of the Food and 
Drug Administration or of any other officer or employee acting on 
behalf of the Secretary of Health and Human Services, such firm, at all 
reasonable hours until at least 2 years after disposal of all such 
color additive, shall make the records and the sample required by 
paragraphs (b)(1) through (b)(3) of this section available to any such 
officer or employee, and shall accord to such officer or employee full 
opportunity to make inventory of stocks of such color additive on hand 
and otherwise to check the correctness of such records.
    (c) The records required to be kept by paragraphs (a) and (b) of 
this section shall be kept separately from all other records.

PART 81--GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR 
PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

    73. The authority citation for 21 CFR part 81 continues to read as 
follows:

    Authority: Secs. 701, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371, 379e).

PART 81--[REMOVED]

    74. Part 81 is removed.

PART 82--LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND 
SPECIFICATIONS

    75. The authority citation for 21 CFR part 82 continues to read as 
follows:

    Authority: Secs. 701, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371, 376, 379e).

PART 82--[REMOVED]

    76. Part 82 is removed.

PART 101--FOOD LABELING

    77. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

    78. Section 101.22 is amended in paragraph (k)(1) by revising the 
first sentence and by removing the phrase ``or part 82'' in the second 
sentence to read as follows:


Sec. 101.22  Foods; labeling of spices, flavorings, colorings and 
chemical preservatives.

* * * * *
    (k) * * *
    (1) A color additive, including a lake, subject to certification 
under section 721(c) of the act shall be declared by the name of the 
color additive listed in the applicable regulation in part 74 of this 
chapter, except that it is not necessary to include the ``FD&C'' prefix 
or the term ``No.'' in the declaration, and for lakes it is also not 
necessary to identify the aluminum cation or alumina substratum, but 
the term ``Lake'' shall be 

[[Page 8417]]
included in the declaration (e.g., Blue 1 Lake). * * *
* * * * *

PART 178--INDIRECT FOOD ADDITIVES; ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    79. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).


Sec. 178.3297  [Amended]

    80. Section 178.3297 Colorants for polymers is amended in paragraph 
(d) by removing the phrase ``, 81, and 82''.

PART 201--LABELING

    81. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: 201, 301, 501, 502, 503, 505, 506, 507, 508, 510 512, 
530-542, 701, 704, 721 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 360, 360b, 
360gg-360ss, 371, 374, 379e); secs 215, 301, 351, 361 of the Public 
Health Service Act (42 U.S.C. 216, 241, 262, 264).


Sec. 201.20  [Amended]

    82. Section 201.20 Declaration of presence of FD&C Yellow No. 5 
and/or FD&C Yellow No. 6 in certain drugs for human use is amended in 
paragraph (a) by adding the words ``or a lake of FD&C Yellow No. 5'' 
before the words ``as a color additive using the names'', in paragraph 
(b) by adding the words ``or a lake of FD&C Yellow No. 5'' before the 
words ``that are administered'', and in paragraph (c) by adding the 
words ``or a lake of FD&C Yellow No. 6'' before the words ``shall 
specifically''.

PART 701--COSMETIC LABELING

    83. The authority citation for 21 CFR part 701 continues to read as 
follows:

    Authority: Secs. 201, 502, 601, 602, 603, 701, 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 361, 362, 
363, 371, 374); secs. 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1454, 1455).

    84. Section 701.3 is amended by redesignating paragraph (c)(1) as 
paragraph (c)(1)(ii) and by adding new paragraph (c)(1)(i) to read as 
follows:

Sec. 701.3  Designation of ingredients.

* * * * *
    (c) * * *
    (1)(i) For color additives, the name of the color additive listed 
in the applicable regulation in part 73 or 74 of this chapter, except 
that it is not necessary to include the ``FD&C'' or ``D&C'' prefix or 
the term ``No.'' in the declaration, but the prefix ``Ext.'' shall be 
included in the declaration. (For example, Ext. D&C Yellow No. 7 may be 
declared as Ext. Yellow 7.) For lakes, it is also not necessary to 
identify the cation precipitants or the substrata, but the term 
``Lake'' shall be included in the declaration. (For example, the name 
of a lake prepared by the extension of FD&C Red No. 40 and D&C Yellow 
No. 10 on alumina and titanium dioxide using aluminum chloride and 
calcium chloride precipitants is ``Red 40 and Yellow 10 Lake.'').
* * * * *
    Dated: February 16, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-4584 Filed 2-29-96; 8:45 am]
BILLING CODE 4160-01-P