Red

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Red 3

• By Jennifer OLeary
• December 13, 2005

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What is Red 3?

• FDC Red 3 the color additive is principally the
  monohydrate of 9 (o- carboxyphenyl)-6-hydroxy-2,4,
  5,7-tetraiodo-3H-xanthen-3-one ,disodium salt,
  with smaller amounts of lower imdinated
  fluoresceins.
• Also known as Erythrosine, a food additive used
  to impart a red color to food. It is used in
  baked goods, cherries, and jellies.

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What is the problem with Red 3?

• FDA terminated the provisional listings for FDC
  Red No. 3 on Jan. 29, 1990, at the conclusion of
  its review of the 200 straight colors on the 1960
  provisional list.

• The provisionally listed uses that were recently
  terminated include use of the straight color in
  cosmetics and externally applied drugs and all
  uses of the lakes of FDC Red No. 3.

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• The case of FDC Red No. 3, however, presents
  what one individual familiar with color
  regulation calls a "regulatory inconsistency."
  Although the provisional uses (about one-third of
  its uses) are now banned, FDC Red No. 3 is still
  permanently listed for use in ingested drugs and
  food, such as baked goods, cherries, dairy
  products, desserts, dietary supplements, food
  seasonings, jellies, jams, and vegetable
  products.

• After the 1960 provisional listings, studies were
  performed on FDC Red No. 3. Results did not show
  any safety concerns, and in response to a
  petition by the Certified Color Manufacturers
  Association (CCMA), FDC Red No. 3 was
  permanently listed for use in ingested drugs and
  foods in June 1969.

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Studies conducted on Red 3

• Cosmetic and externally applied drug uses of the
  color remained provisionally listed while studies
  on skin exposure were conducted. Meanwhile, FDA
  expanded its safety requirements in 1977 to
  include more extensive studies on provisionally
  listed color additives. Based upon the results of
  new studies on FDC Red No. 3, conducted by the
  International Research Development Corporation
  and completed in 1982, the agency concluded that
  FDC Red No. 3 causes thyroid cancer in male
  rats.

• The Cosmetic, Toiletry and Fragrance Association
  and CCMA argued that no direct cancer-causing
  effect was seen in animals given the color in the
  low levels used in consumer goods. FDA, however,
  decided that the evidence of thyroid tumors in
  rats was clear, and that the additional research
  cited by industry did not establish that an
  indirect mechanism--such as a hormonal effect
  triggered by the dye--caused the tumors, rather
  than the dye itself. Thus, FDA denied the
  manufacturers' petition for further permanent
  listings of the color. Based on data from the
  studies, the agency estimated that the lifetime
  risk of thyroid tumors in humans was at most 1 in
  100,000.

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What is the FDAs role?

• The FDA started setting up regulations for color
  additives.There are certain specifications of how
  the addictive red 3 can be made,
  manufactured,labeled, used and certified.
• Manufacturing companies must follow these
  standards.

• Color additive mixtures for food use with FDC
  Red 3 may contain 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.

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Strict Federal Regulations

• Specifications. FDC Red No. 3 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 good manufacturing practice

• Volatile matter (at 135 deg.C.) and chlorides and
  sulfates (calculated as the sodium salts), total
  not more than 13 percent. Water-insoluble matter,
  not more than 0.2 percent. Unhalogenated
  intermediates, total not more than 0.1 percent.
  Sodium iodide, not more than 0.4 percent.
  Triiodoresorcinol, not more than 0.2 percent.
  2(2',4'-Dihydroxy-3', 5'-diiodobenzoyl) benzoic
  acid, not more than 0.2 percent.
  Monoiodofluoresceins not more than 1.0 percent.
  Other lower iodinated fluoresceins, not more than
  9.0 percent. Lead (as Pb), not more than 10 parts
  per million. Arsenic (as As), not more than 3
  parts per million. Total color, not less than
  87.0 percent.

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• Uses and restrictions. FDC Red No. 3 may be
  safely used for coloring foods generally
  (including dietary supplements) in amounts
  consistent with good manufacturing practice
  except that it 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.

• Labeling. The label of the color additive and any
  mixtures
• prepared therefrom intended solely or in part
  for coloring purposes shall conform to the
  requirements of Sec. 70.25 of this chapter.
• Certification. All batches of FDC Red No. 3
  shall be certified
• in accordance with regulations in part 80 of
  this chapter.
• (www.fda.gov)

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Conclusion

• The decision to ban the provisional uses of FDC
  Red No. 3 is based on the Delaney Clause of the
  1960 Color Additive Amendments. Under that
  clause, FDA cannot approve color additives shown
  to induce cancer in humans or animals in any
  amount.
• The ban of the provisionally listed uses of FDC
  Red No. 3 applies to new manufacture and
  production of affected products. Because any
  health risks posed by Red No. 3 are extremely
  small, FDA concluded that consumers may continue
  to use existing supplies of products that already
  contain that color.

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Websites

• http//www.cfsan.fda.gov/lrd/cfr74303.html
• http//www.fda.gov/bbs/topics/CONSUMER/CON00063.ht
  ml
• http//www.fda.gov/bbs/topics/ANSWERS/ANS00136.htm
  l
• http//www.inchem.org/documents/jecfa/jecmono/v024
  je04.htm