[Federal Register: May 20, 2002 (Volume 67, Number 97)]
[Rules and Regulations]               
[Page 35429-35431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my02-4]                         
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 73
 
[Docket No. 00C-0929]
 
 
Listing of Color Additives Exempt From Certification; Sodium 
Copper Chlorophyllin
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Final rule.
 
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SUMMARY: The Food and Drug Administration (FDA) is amending the color 
additive regulations to provide for the safe use of sodium copper 
chlorophyllin as a color additive in citrus-based dry beverage mixes. 
This action is in response to a petition filed by Kraft Foods, Inc.
 
DATES: This rule is effective June 20, 2002; except as to any 
provisions that may be stayed by the filing of proper objections. 
Submit written or electronic objections and requests for a hearing by 
June 19, 2002.
 
ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic objections and requests for a 
hearing to http://www.fda.gov/dockets/ecomments.
 
FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 202-418-3076.
 
SUPPLEMENTARY INFORMATION:
 
I. Introduction
 
    In a notice published in the Federal Register of March 14, 2000 (65 
FR 13770), FDA announced that a color additive petition (CAP 0C0270) 
had been filed by Kraft Foods, Inc.,c/o Flamm Associates, 622 Beachland 
Blvd., Vero Beach, FL 32963. The petition proposed to amend the color 
additive regulations to provide for the safe use of sodium copper 
chlorophyllin to color citrus-based dry beverage mixes.
 
II. Identity
 
    Sodium copper chlorophyllin is manufactured from chlorophyll, the 
common pigment of green plants. The manufacturing process consists of 
three main steps: (1) Extraction of chlorophyll from plant material 
with an appropriate solvent, (2) preparation of water-soluble 
derivatives by alkaline hydrolysis of ester groups of chlorophyll 
(saponification), and (3) replacement of the magnesium ion of natural 
chlorophyll with copper. The final color additive product sodium copper 
chlorophyllin is a complex mixture of chlorophyll derivatives (Ref. 1). 
The petitioner specified the source of chlorophyll used to make sodium 
copper chlorophyllin as alfalfa (Medicago sativa) and provided data 
showing that sodium copper chlorophyllin prepared from chlorophyll 
extracted from alfalfa meets the proposed specifications. Therefore, in 
new Sec. 73.125 (21 CFR 73.125) FDA is limiting the source of 
chlorophyll used to make sodium copper chlorophyllin to alfalfa.
    The agency notes that the intended coloring effect of citrus-based 
dry beverage mixes is achieved when sodium copper chlorophyllin is used 
in an amount not exceeding 0.2 percent. Therefore, in new Sec. 73.125 
the agency is limiting the amount of sodium copper chlorophyllin in the 
dry mix to 0.2 percent.
 
III. Safety Evaluation
 
    In evaluating the safety of the use of sodium copper chlorophyllin 
to color citrus-based dry beverage mixes, the agency considered: (1) 
The safety of chlorophyll and copper chlorophyllins, including the 
manufacturing process of sodium copper chlorophyllin; and (2) the 
safety of copper in sodium copper chlorophyllin.
 
[[Page 35430]]
 
A. Safety of Chlorophyll and Copper Chlorophyllins
 
    Chlorophyll occurs naturally in green vegetables and as such 
constitutes a normal part of the human diet. Various derivatives of 
chlorophyll, generally referred to as copper chlorophyllins or 
chlorophyllin copper complexes, including sodium copper chlorophyllin, 
are commonly used food colors (Refs. 1 and 2). In the United States, 
potassium sodium copper chlorophyllin has been listed for use as a 
color additive in dentifrices that are either drugs (21 CFR 73.1125) or 
cosmetics (21 CFR 73.2125). In addition, FDA permits over-the-counter 
use of chlorophyllin copper complex as an internal deodorant in doses 
up to 300 milligrams (mg) daily (21 CFR 357.850).
    FDA calculated the estimated daily intake (EDI) of sodium copper 
chlorophyllin that will result from the petitioned use for 90th 
percentile consumers older than 2 years as 90 mg/person/day(d). During 
this calculation, the agency also considered the exposure to the color 
additive from its uses in dentifrices, and determined that such 
exposure would be negligible. The agency reviewed a published study 
submitted with the petition in which potassium sodium copper 
chlorophyllin was fed to rats at levels up to 3 percent in the feed for 
up to 2 years (Ref. 3). The agency determined that the results of the 
study showed no indications of adverse effects in rats at any of the 
doses tested from the prolonged consumption of the color additive. In 
addition, there was no evidence of metal toxicity. Moreover, evaluating 
the same study, the Joint Food and Agriculture Organization/World 
Health Organization (FAO/WHO) Expert Committee on Food Additives 
(JECFA) also found no adverse effects and established 1,500 mg/kilogram 
(kg) body weight/d as the no observed effect level (NOEL) of sodium 
copper chlorophyllin (Ref. 4). By applying a 200-fold safety factor to 
this NOEL, the agency calculated the acceptable daily intake (ADI) for 
sodium copper chlorophyllin for a 60-kg human as 450 mg/person/d. The 
agency notes that the EDI of sodium copper chlorophyllin that will 
result from the petitioned use for 90th percentile consumers is one-
fifth of this ADI. Therefore, FDA concludes that the exposure to sodium 
copper chlorophyllin from the petitioned use does not pose a safety 
concern (Ref. 5).
    During its safety review, FDA also evaluated the manufacturing 
process of sodium copper chlorophyllin. The agency is specifying in new 
Sec. 73.125 the solvents that may be used to manufacture sodium copper 
chlorophyllin and is establishing a specification for the residues of 
these solvents that do not present a safety concern and thus may be 
present in the final product.
 
B. Safety of Copper in Sodium Copper Chlorophyllin
 
    The petitioner provided data showing that the amount of free 
(ionizable) copper in sodium copper chlorophyllin does not exceed 200 
parts per million (ppm). Therefore, new Sec.  73.125 specifies the 
amount of free copper in sodium copper chlorophyllin as not more than 
200 ppm. Using this limit, FDA calculated the EDI of free copper from 
the consumption of sodium copper chlorophyllin for 90th percentile 
consumers older than 2 years as 0.018 mg/person/d. The agency also 
considered the exposure to copper from the uses of the color additive 
in dentifrices and determined that this exposure would be negligible. 
The agency notes that copper is an essential element and a dose of 2 
mg/d is the reference daily intake (RDI) (21 CFR 101.9(c)(8)(iv)). 
Because the EDI for 90th percentile consumers is less than 1 percent of 
the RDI, the agency believes that the additional exposure of 0.018 mg/d 
to copper from the petitioned use will not pose a safety concern (Ref. 
6).
 
IV. Conclusion
 
    Based on the data in the petition and other relevant material, FDA 
concludes that the petitioned use of sodium copper chlorophyllin as a 
color additive in citrus-based dry beverage mixes is safe, the additive 
will achieve its intended technical effect, and thus, it is suitable 
for this use. FDA concludes that 21 CFR part 73 should be amended as 
set forth below. In addition, based upon the factors listed in 21 CFR 
71.20(b), FDA concludes that certification of sodium copper 
chlorophyllin is not necessary for the protection of the public health.
 
V. Inspection of Documents
 
    In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the 
documents that FDA considered and relied upon in reaching its decision 
to approve the petition are available for inspection at the Center for 
Food Safety and Applied Nutrition (address above) by appointment with 
the information contact person listed above. As provided in Sec. 71.15, 
FDA will delete from the documents any materials that are not available 
for public disclosure before making the documents available for 
inspection.
 
VI. Environmental Impact
 
    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for CAP 0C0270 (65 FR 
13770, March 14, 2000). No new information or comments have been 
received that would affect the agency's previous determination that 
there is no significant impact on the human environment and that an 
environmental impact statement is not required.
 
VII. Paperwork Reduction Act of 1995
 
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
 
VIII. Objections
 
    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by June 19, 2002. Each objection shall be separately 
numbered, and each numbered objection shall specify with particularity 
the provisions of the regulation to which objection is made and the 
grounds for the objection. Each numbered objection on which a hearing 
is requested shall specifically so state. Failure to request a hearing 
for any particular objection shall constitute a waiver of the right to 
a hearing on that objection. Each numbered objection for which a 
hearing is requested shall include a detailed description and analysis 
of the specific factual information intended to be presented in support 
of the objection in the event that a hearing is held. Failure to 
include such a description and analysis for any particular objection 
shall constitute a waiver of the right to a hearing on the objection. 
Three copies of all documents are to be submitted and are to be 
identified with the docket number found in brackets in the heading of 
this document. Any objections received in response to the regulation 
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday. FDA will publish notice of the objections that 
the agency has received or lack thereof in the Federal Register.
 
IX. 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. Hendry, G. A. F., ``Chlorophylls and Chlorophyll 
Derivatives,'' in ``Natural Food Colorants,'' 2d ed., pp. 131-156, 
edited by
 
[[Page 35431]]
 
Hendry, G. A. F. and J. D. Houghton, Blackie Academic & 
Professional, New York, 1996.
    2. European Parliament and Council Directive 94/36/EC of June 
30, 1994, on colours for use in foodstuffs, Official Journal of the 
European Communities, L 237:17-18, 1994.
    3. Harrisson, J. W. E., S. E. Levin, and B. Trabin, ``The Safety 
and Fate of Potassium Sodium Copper Chlorophyllin and Other Copper 
Compounds,'' Journal of the American Pharmaceutical Association, 
43:722-737, 1954.
    4. ``Toxicological Evaluation of Some Food Colours, Enzymes, 
Flavour Enhancers, Thickening Agents, and Certain Other Food 
Additives,'' Joint FAO/WHO Expert Committee on Food Additives, WHO 
Food Additives Series, No. 6, pp. 74-77, Geneva, 1975.
    5. Ikeda, G. J., Memorandum entitled ``Addendum to Toxicology 
Review Memorandum of June 14, 2000'' from the Division of Food 
Contact Substance Notification Review (HFS-225) to the Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, FDA, November 21, 2001.
    6. Ikeda, G. J., Memorandum entitled ``Toxicology Review; Use of 
Sodium Copper Chlorophyllin as a Colorant for Citrus-based Dry 
Beverage Mix'' from the Division of Health Effects Evaluation (HFS-
225) to the Division of Petition Control (HFS-215), Center for Food 
Safety and Applied Nutrition, FDA, June 14, 2000.
 
List of Subjects in 21 CFR Part 73
 
    Color additives, Cosmetics, Drugs, Medical devices.
 
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 73 is amended as follows:
 
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
 
    1. The authority citation for 21 CFR part 73 continues to read as 
follows:
 
    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.
    2. Section 73.125 is added to subpart A to read as follows:
 
 
Sec. 73.125  Sodium copper chlorophyllin.
 
    (a) Identity. (1) The color additive sodium copper chlorophyllin is 
a green to black powder prepared from chlorophyll by saponification and 
replacement of magnesium by copper. Chlorophyll is extracted from 
alfalfa (Medicago sativa) using any one or a combination of the 
solvents acetone, ethanol, and hexane.
    (2) Color additive mixtures made with sodium copper chlorophyllin 
may contain only those diluents that are suitable and are listed in 
this subpart as safe for use in color additive mixtures for coloring 
foods.
    (b) Specifications. Sodium copper chlorophyllin shall conform to 
the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
good manufacturing practice:
(1) Moisture, not more than 5.0 percent.
(2) Solvent residues (acetone, ethanol, and hexane), not more than 50 
parts per million, singly or, in combination.
(3) Total copper, not less than 4 percent and not more than 6 percent.
(4) Free copper, not more than 200 parts per million.
(5) Lead (as Pb), not more than 10 parts per million.
(6) Arsenic (as As), not more than 3 parts per million.
(7) Mercury (as Hg), not more than 0.5 part per million.
(8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 nm, 
not less than 3.4 and not more than 3.9.
(9) Total copper chlorophyllins, not less than 95 percent of the sample 
dried at 100  deg.C for 1 hour.
    (c) Uses and restrictions. Sodium copper chlorophyllin may be 
safely used to color citrus-based dry beverage mixes in an amount not 
exceeding 0.2 percent in the dry mix.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom shall conform to the requirements of 
Sec. 70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification 
requirements of section 721(c) of the act.
 
    Dated: April 25, 2002.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 02-12544 Filed 5-17-02; 8:45 am]
BILLING CODE 4160-01-S