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

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