U. S. Food and Drug Administration
Center for Food Safety and Applied
Nutrition
Office of Cosmetics Fact Sheet
March 30, 2000
Prohibited Ingredients and Related Safety Issues
By law, FDA does not have the authority to approve cosmetic products or
ingredients, except for color additives. However, regulations prohibit or
restrict the use of several ingredients because of safety concerns.
In addition, cosmetic and fragrance trade associations have recommended
avoiding or limiting the use of some substances. Contaminants raise additional
concerns. The following is an introduction to special safety and regulatory
issues related to cosmetic ingredients.
Substantiation of safety
It is the responsibility of the manufacturer and distributor to assure the
safety of each ingredient and finished product. Without substantiation of
safety, Title 21 of the Code
of Federal Regulations (21 CFR), Part 740.10 requires that the product carry
the following warning on the label:
"Warning: The safety of this product has not been
determined."
Ingredients prohibited or restricted by regulation
Regulations specifically prohibit or restrict the use of the following
ingredients in cosmetics. For complete details, refer to the relevant
regulations (21 CFR,
Parts 250.250 and 700.11 through 700.23):
- Hexachlorophene. Because of its neurotoxic effect and ability to
penetrate human skin, hexachlorophene (HCP) may be used only when an
alternative preservative has not been shown to be as effective. The HCP
concentration of the cosmetic may not exceed 0.1 percent, and it may not be
used in cosmetics that in normal use may be applied to mucous membranes, such
as the lips.
- Mercury compounds. Mercury compounds are readily absorbed through
the skin on topical application and tend to accumulate in the body. They may
cause allergic reactions, skin irritation, or neurotoxic manifestations. The
use of mercury compounds as cosmetic ingredients is limited to eye area
cosmetics at concentrations not exceeding 65 parts per million (0.0065
percent) of mercury calculated as the metal (about 100 ppm or 0.01 percent
phenylmercuric acetate or nitrate) and provided no other effective and safe
preservative is available for use. All other cosmetics containing mercury are
adulterated and subject to regulatory action unless it occurs in a trace
amount of less than 1 part per million (0.0001 percent) calculated as the
metal andits presence is unavoidable under conditions of good manufacturing
practice.
- Chlorofluorocarbon propellants. The use of chlorofluorocarbon
propellants (fully halogenated chlorofluoroalkanes) in cosmetic aerosol
products intended for domestic consumption is prohibited.
- Bithionol, because it may cause photo-contact sensitization.
- Halogenated salicylanilides (di-, tri-, metabromsalan and
tetrachlorosalicylanilide), because they may cause photocontact sensitization.
- Chloroform, because of its animal carcinogenicity and likely hazard
to human health.
- Vinyl chloride, as an ingredient of aerosol products, because of
its carcinogenicity.
- Zirconium-containing complexes, in aerosol cosmetic products,
because of their toxic effect on lungs, including the formation of granulomas.
- Methylene chloride, because of its animal carcinogenicity and
likely hazard to human health.
Methyl methacrylate monomer: The subject of a court ruling
In the early 1970s, FDA received a number of complaints of personal injury
associated with the use of fingernail extenders containing methyl methacrylate
monomer. Among these injuries were reports of fingernail damage and deformity,
as well as contact dermatitis. On the basis of its investigations of the
injuries and discussions with medical experts in the field of dermatology, FDA
concluded that liquid methyl methacrylate was a poisonous and deleterious
substance that should not be used in fingernail preparations. The agency chose
to remove products containing 100 percent liquid methyl methacrylate monomer
through court proceedings, which resulted in a preliminary injunction against
one firm as well as several seizure actions and voluntary recalls.
Although there is no specific regulation prohibiting the use of liquid methyl
methacrylate monomer in cosmetic products, FDA continues to believe that this
substance, when used in cosmetic fingernail preparations, is a poisonous and
deleterious substance.
Color additives
Color additives are strictly regulated. In order to
protect consumers from harmful contaminants, many cannot be used unless the
color comes from a batch certified by FDA and that batch is provided with its
own individual certification lot number. Their uncertified counterparts are not
allowed and addition of the color to a product will make the entire product
adulterated. While colors exempt from certification are not subject to such
testing, manufacturers must assure that each color additive complies with the
identity, specifications, labeling requirements, use, and restrictions of color
additive regulations. With the exception of coal-tar hair dyes, all color
additives - whether or not they are subject to certification - must be approved
by FDA for their intended use. Check FDA's color listings to
determine whether a color additive is approved for your intended use and whether
it is subject to certification requirements.
Trade associations recommend eliminating or limiting the use of some
substances
In addition to the ingredients that are controlled by regulation or were the
subject of a court ruling, cosmetic and fragrance trade associations have
recommended eliminating or limiting maximum levels of certain ingredients
associated with health risks. For example, the Cosmetic Ingredient Review (CIR) Expert
Panel, an independent panel of scientific experts, regularly assesses the
safety of numerous cosmetic ingredients and publishes its findings. (The CIR was
established by the Cosmetic, Toiletry, and
Fragrance Association.) According to its 1999 Annual Report, CIR has found
the following ingredients unsafe:
- Chloroacetamide (a preservative), because of sensitization
(development of allergic reactions).
- Ethoxyethanol and Ethoxyethanol Acetate (a solvent), because
of reproductive and developmental toxicity.
- HC Blue No. 1 (a hair coloring ingredient), because of possible
carcinogenicity.
- p-Hydroxyanisole (an antioxidant), because of skin depigmentation.
- 4-Methoxy-m-Phenylenediamine, 4-Methoxy-m-Phenylenediamine HCl, and
4-Methoxy-m-Phenylenediamine Sulfate (hair dye ingredients), because of
possible carcinogenicity.
- Pyrocatechol (used in hair dyes and skin care preparations),
because of carcinogenic and co-carcinogenic potential. (CIR describes this
substance as unsafe for leave-on products and considers available data
insufficient to assure safety for use in hair dyes.)
CIR also has recommended limits for the use of a number of other ingredients.
You can contact CIR at:
Cosmetic Ingredient Review
1101 17th St. N. W. Suite 310
Washington D. C. 20036-4702
phone: 202-331-0651 fax: 202-331-0088
Web site: http://www.cir-safety.org/
Similarly, the International Fragrance
Association (IFRA) establishes usage guidelines for fragrance materials.
IFRA's Code of Practice currently recommends against the use of more than 30
substances as fragrance materials and advises limiting the use of many more.
Among the many that IFRA recommends avoiding are:
- Acetylethyltetramethyltetralin (AETT), because of neurotoxicity.
- Musk Ambrette, because of photocontact sensitization.
- 6-Methylcoumarin (6-MC), because of photocontact sensitization.
The IFRA member organization in the United States is:
Fragrance Materials Association (FMA)
1620 I St., NW, Suite 925
Washington, DC 20006
Phone: (202) 293-5800
Fax: (202)
463-8998
Contaminants raise concerns
The risk of introducing contaminants into a product is always a concern in
cosmetic manufacture, whether they are introduced through contaminated raw
ingredients or form during the manufacturing process. Nitrosamines and dioxane
are among those contaminants that may form during the manufacturing process and
raise safety issues. Research also has raised safety questions about diethanolamine (DEA) and
related ingredients that may contain residual levels of this substance.
- Nitrosamines. Many nitrosamines have been determined to cause
cancer in laboratory animals. They also have been shown to penetrate the
skin.
FDA expressed its concern about the contamination of cosmetics with
nitrosamines in a notice published in the Federal Register of April 10, 1979 (44
FR 21365). It stated that cosmetics containing nitrosamines may be considered
adulterated and subject to enforcement action.
Cosmetics containing as ingredients amines or amino derivatives, particularly
diethanolamine, or ingredients that are derived from diethanolamine or possibly
contain diethanolamine as a contaminant, may form nitrosamines if they also
contain an ingredient that acts as a nitrosating agent, such as
2-bromo-2-nitropropane-1,3-diol (Bronopol), 5-bromo-5-nitro-1,3-dioxane
(Bronidox L) or tris(hydroxymethyl)nitromethane (Tris Nitro), or if they are
contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their
derivatives are mostly present in creams, cream lotions, hair shampoos, and
cream hair conditioners. Nitrosamines are avoidable by proper formulation: by
not using amines or amino derivatives in combination with a nitrosating agent
and by testing the product under use conditions to make sure that nitrosamines
do not form under customary conditions of use.
- Dioxane. In rodent feeding studies conducted for the National Cancer Institute, 1,4-dioxane was
found to produce cancer of the liver and the nasal turbinates. It also caused
systemic cancer in a skin painting study. Skin absorption studies demonstrated
that dioxane readily penetrates animal and human skin from various types of
vehicles, although it is uncertain how much is available for absorption and
how much evaporates instead of penetrating the skin.
Cosmetics containing as ingredients ethoxylated surface active agents,
including detergents, foaming agents, emulsifiers and certain solvents
identifiable by the prefix, word, or syllable "PEG," "Polyethylene,"
"Polyethylene glycol," "Polyoxyethylene," "-eth-," or "-oxynol-," may be
contaminated with 1,4-dioxane. It may be removed from ethoxylated compounds by
means of vacuum stripping at the end of the polymerization process without an
unreasonable increase in raw material cost.
Avoiding prohibited ingredients through FDA's Cosmetic Voluntary
Registration Program
Although cosmetic manufacturers are not required to register with FDA,
companies are encouraged to register their establishments and list their
products and ingredients through the agency's Cosmetic Voluntary
Registration Program (CVRP). If a cosmetic manufacturer files a product
formulation with the CVRP, FDA can advise the manufacturer if he or she is
inadvertently using a non-permitted color additive or other prohibited or
restricted ingredients. In this way, manufacturers can correct their
formulations before attempting to import or distribute them, thus avoiding the
risk of detention or recall due to
ingredient-related violations. Products containing prohibited ingredients are
not accepted into the registration program.
The information received by FDA from the CVRP is evaluated and entered into a
computer database. If it is determined that a cosmetic ingredient presently
being used is harmful and should be removed from product use, FDA can notify the
product's manufacturer or distributor by using a mailing list generated from the
CVRP database. If your products are not in the registration database, you won't
be on the notification mailing list.
For Safe
Products without harmful chemicals
