Fragrance Safety: A Closer Look at
Industry's Answers
Information compiled by Betty Bridges
Presented at the April 28th FDA Conference in Chicago by Karen
Truskowski of
MCS: Health & Environment
(a support group from the Chicago area)
A person easily uses a dozen or more fragranced products in a day. Many of these
products are applied directly to the skin. [1] The users of these products
assume the safety of the materials used in them, and the final product has been
established. It never occurs to most people that this is not the case. [2]
Fragranced products such perfumes, colognes, and personal care items come under
the jurisdiction of the FDA. However, due to "trade secret" status of fragrance
formulas the fragrance industry is basically self regulated. The ingredients
used in fragrance formulas do not have to be disclosed to anyone, even the FDA.
Increasingly fragranced products are cited as triggering or causing health
problems. Though the industry has in place procedures for establishing the
safety of fragrance materials, these measures are not adequate. The industry has
been slow to address the issues involved. The answers provided by the industry
need closer examination.
1. Fragrance materials have a long history of relatively safe use.
It is true that fragrances have been used for centuries. However, until the late
1860s virtually all fragrance materials were obtained from plant and animal
sources. Though often concentrated through distillation, the materials
contained, were close to that found in nature. No one chemical was found in
isolation. Companion chemicals found together often had synergistic and
modifying effects.
The majority of modern fragrance materials are synthesized from petroleum
products. Many are not found in nature. There is no long history of use. The
materials that are obtained from plant material are often extracted as isolates.
This means individual chemicals rather than the complex mixtures found in nature
are used. History of use no longer applies, as the action of individual
chemicals may be far different than in mixtures. [2]
2. Compounds are used at such low levels that they are not a health
risk.
The current trend in fragrance formulation is toward using powerful long lasting
synthetics at higher levels. One material may make up as much as 25% of the
formula. It is not unusual for four or five materials to make up 80% of the
formula. [3]
3. Fragrance materials are safety tested.
The Research Institute for Fragrance Materials (RIFM) safety tests fragrance
materials. Only about 1300 of the more than 5000 materials used in fragrances
have been tested for safety. The testing that is done is generally limited to
acute oral and dermal toxicity, irritation and dermal sensitization, and
phototoxicity. Testing is limited to individual materials, there is little
effort to address synergistic and modifying effects of materials in combination
though the RIFM is aware that they occur. Early on in testing it was found that
when similar materials were tested together more positive sensitization
reactions occurred than when the materials were tested individually. Testing
procedures were changed so only unrelated materials were used in a testing
sequence. [4]
Most chemical data sheets and MSDS information on fragrance materials plainly
state: "The chemical, physical, and toxicological properties have not been
thoroughly investigated."[5]
4. Present testing is adequate.
Musk ambrette was found to have neurotoxic properties. This was first discovered
in 1967 when mice were feed varying levels of musk ambrette. Since dietary
consumption of musk ambrette is generally very low, the impact was discounted
and no assessment was made of exposures from fragranced products. In 1985 after
studies were published on the neurotoxic effects and it was determined musk
ambrette was readily absorbed through the skin, the IFRA recommended that Musk
ambrette not be used in direct skin contact products. Musk ambrette had been
used in fragranced products since before the 1920s. [6]
Versalide (AETT) had been used in the fragrance industry since the 1950s. In the
mid-70s it was discovered by accident that this material was severely neurotoxic
and caused the internal organs of mice to turn blue. [7]
Perfumes and fragrances are recognized as triggers for asthma by the American
Lung Association and other organizations concerned about respiratory health.
[8], [9]
In spite of legitimate concerns, the industry does not include testing for the
neurological and respiratory effects of fragrance materials.
5. The industry can adequately regulate itself to ensure the safety of
fragranced products.
The International Fragrance Association (IFRA) takes the information obtained
from the RIFM materials and establishes guidelines for safe use of fragrance
materials. These guidelines are not binding and there is no enforcement by the
industry.
In 1985 the IFRA recommended that Musk ambrette not be used in direct skin
contact products. In 1991, the FDA still found Musk ambrette in skin contact
products.
Musk xylol is found in water ways and aquatic wildlife. It is being found in
human adipose tissue and breast milk. In spite of this the IFRA has made no
restrictions or recommendations concerning its use.
6. Only a small segment of the population has adverse effects from
fragrances.
1-2% of the population has skin allergies to fragrances. Fragrance is one of the
most common causes of adverse reactions to cosmetics. [10], [11]
Asthma rates have doubled in the past twenty years. In 1994 there were over 14
million asthmatics. [12] Perfumes and colognes trigger 72% of asthmatics. [13]
Each year over 35 million people suffer from sinusitis. [14] Fragrances are
general irritants that contribute to the incidence of sinus problems. For some
they are the primary triggers for upper and lower respiratory illnesses.
Migraines effect as many as 25 million people. Fragrances are known triggers for
migraine headaches. [15]
Many other health conditions are adversely affected by fragrances. Those with
chronic lung disease find exposure to fragrances exacerbate their condition.
Those receiving chemotherapy for treatment of cancer often find exposures
nauseating.
In Canada, fragrance manufactures have developed an organization called
ScentedProducts Education and Information Association of Canada This
organization has a web site that addresses Multiple Chemical Sensitivity (MCS)
and the issues raised by those with MCS that are adversely affected by others
fragrance use. The controversial aspects of MCS are used to downplay the
significance of fragrances as a health issue. There is no mention of impact on
health of those with asthma, allergies, upper respiratory problems, chronic lung
disease, or migraine headaches; conditions that are well documented in medical
literature as adversely affected by fragranced products.
In the US, Glenn Roberts, spokesperson for the Research Institute for Fragrance
Materials says the industry is not aware of any increased complaints. [17]
However, the issue of fragrance sensitivity was discussed at the 1996 CTFA
Scientific Conference and Annual Trade Show. The industry was aware of the
Berkeley, California proposal to ban fragrances at public meetings and other
efforts to curtail exposure to fragranced products.
" This attempt to regulate fragrances was not one isolated incident. In
Massachusetts, there is an effort to regulate fragrance inserts in magazines.
One possible solution may be to require odorless sealed packets for all
fragrance samples; resolving this issue may very well involve the U.S. Postal
Service because it regulates the use of such inserts." [18]
Though the issue of Multiple Chemical Sensitivity has brought attention this
issue, the adverse effects of fragrances is a general health issue that affects
millions of Americans on a daily basis and should be of concern for everyone. It
is unfortunate the industry has chosen not to address this issue in a
responsible manner. This short sightedness only serves to increase doubts over
the industry's ability to regulate itself.
In light of the Fragrance Industry's unwillingness to adequately address the
issue of fragrance safety, it is time for the FDA to intervene. Though FDA
resources are limited there are cost effective means of acting and ensuring the
safety of the public's health. Programs and resources already in place can be
utilized to more effectively monitor the safety of fragranced products.
Make available "fact sheets" that acknowledges exposure to fragrances can
exacerbate or trigger asthma, sinus and upper respiratory problems, migraines
and other disorders. It is important that consumers are aware that the FDA does
not require pre-market testing of products. Many parents with asthmatic children
are not aware that the products they use may be contributing to their child's
illness. Such education would also increase the awareness that "second hand"
fragrance can cause problems for others. Many parents are also unaware of the
general consensus among pediatricians that fragranced products should not be
used on infants.
Expand the Cosmetic Adverse Reaction Monitoring so that complaints can be
registered via the FDA web site. This would make it easier to file complaints.
Data could be used to pinpoint specific products that are problematic.
The National Center for Toxicological Research can be utilized to analyze
fragrances that are problematic. The results can be examined to determine if
there are substances or formulations that common in the products that complaints
have been filed. Further the results of analysis can be examined to be sure
materials banned (voluntarily or by law) are not present. Also any lack of
compliance with IFRA recommendations for restricted materials should be noted.
The product should also be examined for proper labeling, etc.
The vast numbers of materials used in fragrances makes the task of ensuring
safety of each and every substance beyond the scope of the FDA's resources.
However, by closer examination, several reasonable points to start can be
determined. The "Fragrance Mix" patch testing is diagnostics for the majority of
skin allergies to fragrances. These materials would be a good place to start in
determining if fragrance materials can also act as respiratory sensitizers.
More complaints are registered concerning fragrances formulated since the
mid-eighties. Examination of these products may provide clues as to why these
formulations are frequently cited as causing problems. Materials were brought
into common use should be closely examined. Some materials may have been used on
a limited basis previously, but newer information increased their use. For
example in the late seventies it was found that amylcinnamaldehyde and
hexylcinnamaldehdye had the ability to hold the scent even after washing and
rinsing. Though both of the materials had been in use for some time, usage in
products with a "wet" application increased.
Materials introduced in the past several decades needs to be closely monitored,
as they have no history of use. This is especially true of the newer materials
that are used at relatively high levels in modern fragrance formulas. Fragrance
materials are not the only things that need examining. Newer technologies such
as the use of cyclodextrins also need to be examined to determine if the use of
such materials add to the health risks.
Though health risks from an individual fragrance may seem insignificant, the
sheer numbers of fragranced products used make them a concern. Further
bioaccumulation of fragrance materials increases the concern. Presence of
fragrance chemicals in fat tissue and breast milk raises the issues of effects
on the fetus and nursing infants. These are health concerns that should not be
ignored. Increases in asthma and other respiratory problems triggered by
fragrance exposure raises concerns over effects on the airways and the lungs.
These and other concerns need to be addressed by the FDA and the fragrance
industry.
REFERENCES:
1. Fundamentals of cosmetic product safety testing. Cosmetics and Toiletries Oct
1996 (v111 n10) Start Page: p79(7) ISSN: 0361-4387 Romanowski, Perry Schueller,
Randy
2. Safeguards in the use of fragrance chemicals. Cosmetics and Toiletries Feb
1997 (v112 n2) Start Page: p47(7) ISSN: 0361-4387 Hostynek, Jurij J.
3. Perfumery: Practice and Principles; Calkin RJ, Jellinek JS; pg 139; John
Wiley & Sons, Inc, 1994
4. Safety Testing of Fragrances: Problems and Implications Opydyke D. L.;
Clinical Toxicology 10(1), pp 61-77 (1977)
5. MSDS for Aldrich Flavors & Fragrance chemicals
6. Nitro musks in fragrance products: an update of FDA findings.Cosmetics and
Toiletries June 1996 (v111 n6) Start Page:73(4) ISSN: 0361-4387 Wisneski, Harris
S. Havery, Donald C.
7. Dictionary of Toxicology 2nd Edition
acetylethyltetramethyltetramin (AETT; polycyclic musk; musk
tetralin; Versalide; Musk 26A; 1,1,4,4 - tetramethyl - 6 -
ethyl - 7 - acetyl - 1,2,3,4 - tetrahydronaphthaline). CAS number
83-29-9. de Groot AC, et al.
8. Journal of the American Medical Association, Asthma
Information Center
9. American Lung Association(r) Offers Indoor Air Tips for People
With Allergies and Asthma
10. Adverse reactions to fragrances. A clinical review. de Groot
AC, et al. Contact Dermatitis. 1997 Feb;36(2):57-86
11. Perfume Causes Allergy DanishEnvironment, Internet Edition 2, September
1996
12. American Lung Association: Asthma Fact Sheet
13. Shim, Chang, M.D., Williams, M. Henry, Jr., "Effects of Odors on Asthma."
The American Journal of Medicine, Volume 80, January 1986, pp. 18-22
14. Getting the facts about...Sinus Pain, Drainage, & Infection from the
American Academy of Otolaryngology - Head and Neck Surgery Public Service
Brochure.
15. Excedrin Headache Resource Center on the Internet
16. Scented Products Education and Information Association of Canada. http://www.scentedproducts.on.ca/
17. Fisher, Brandy E. Scents & Sensitivity Environmental Health Perspectives
Volume 106, December 12, 1998
18. Knutson-Strack, Amy. CTFA Scientific Conference and Annual Trade Show:
adverse reactions and claims; Cosmetics and Toiletries; (v112 n2) Start Page:
p35(2) ISSN: 0361-4387