Statement of Betty Bridges, R.N.
fpinva@fpinva.org

www.fpinva.org

Industry Motivation: Personal Rights or Profits

June 20, 2000, Halifax, Nova Scotia

The fragrance industry has been quite vocal on the restriction of the use of fragranced products in Halifax, Nova Scotia. They have expressed indignant outrage at what they describe as a threat to individual freedoms. While it is asserted there are no scientific data to support concerns, there has been no presentation of scientific data on the part of the industry to dispel health concerns. And there has been little concern for the rights of those negatively impacted by fragranced products, nor any concern for consumers' "right to know" so that informed choices may be made.

For all its assertions that scientific data to support concerns do not exist, there has been no opportunity for the scientific data that is available to be presented. There is an increasing body of scientific, medical, and industry literature that supports concerns over health, safety, and environmental aspects of fragrances. Rather than responsibly address these recognized issues the industry has chosen to play upon controversy of Multiple Chemical Sensitivity.

There are mounting reasons for the industry to be concerned. A petition before the FDA in the U.S. asks that existing labeling laws be enforced. The publicity over the events in Halifax threatens the image and profits of the industry. In Europe changes that will require labeling of skin sensitizers are imminent. These are the reasons for the industry's great financial concern, which are thinly disguised by assertions that personal freedoms are at stake.

Unfortunately, many of these issues have been misrepresented in the media coverage of the "scent debate" in Nova Scotia. Questions raised by the article "Cosmetics industry wafts into Nova Scotia's scent debate" by Jonathon Gatehouse from the Tuesday, April 25, 2000 issue of THE NATIONAL POST are addressed below along with a summary of concerns supported by scientific, medical, and industry data.

Assertion #1: Fragrance has been used for centuries with few adverse effects. History of use indicates fragrances are safe.

Rebuttal: Fragrant materials have been used for centuries. Up until the 1800s the primary use was medicinal, religious, and ceremonial purposes. These materials were thought to have powers to ward off disease and prevent harm. The elite used scented oils to enhance beauty. Cleopatra is famous for such use, but this use was limited to those with power. Up until the late 1800s the raw materials were obtained from plant and animal sources.(1)

Modern fragrances are primarily synthetic materials developed since World War II.(2) Multiple fragranced products are now used on a daily basis.(3) Both materials exposed to and the amounts of exposure are vastly different from centuries ago nullifying any comparison and voiding any validity to history of use.


Assertion #2: "People have had the freedom to use fragrances and scented products for centuries, both for their enjoyment as well as personal hygiene." (Charles Low, president of Canadian Cosmetic Toiletry and Fragrance Association)

Rebuttal: Fragrance was used to mask the stench of unwashed bodies during a period when bathing and personal hygiene was greatly lacking, not as a part of personal hygiene. Perfumery as a distinct entity used strictly for its scent properties did not exist until about the 1800s.(1)


Assertion #3: There is no scientific evidence to justify all out fragrance bans.

Rebuttal: There are actually considerable scientific data available to support bans on fragrances in certain environments. There is certainly enough evidence to support health, safety, and environmental concerns. A review of existing medical, scientific, and industry literature yields considerable data. Though in relationship to the use and exposure to fragrance materials, the available information is extremely sparse. This further reflects concerns of the fragrance industry's ability to adequately ensure the safety of its products with little oversight and regulation. These concerns are reflected by the analysis of a popular perfume.

Consider what chemicals are actually in a typical modern perfume.

In 1999 several concerned individuals frustrated with the lack of available information had the popular fragrance Eternity by Calvin Klein analyzed by a company that is a member of the International Fragrance Association and specializes in the analysis of fragrance and flavors. Due to limited resources and the high cost of analysis, only one product could be analyzed. This particular perfume was chosen because it was frequently mentioned as triggering adverse symptoms and it was typical of modern products, which are very strong and long lasting.

The analysis* revealed substances that were present at levels down to 0.1% in the product. Forty-one substances were revealed. Available health and safety data was then researched on these materials. Available literature revealed that substances in the product included materials that were toxic, respiratory and skin irritants, respiratory and skin sensitizers, possible carcinogens, had central nervous system effects, and were possible hormone disruptors. The chemical, physical, and toxicological properties had not been thoroughly investigated on most of the materials. The material at the highest level; Iso E Super, a very common fragrance material, had no publicly available health and safety data.(4)

 

Based on this data the Environmental Health Network of California filed a petition with the FDA asking that this perfume be declared misbranded because it contained materials, which the safety of had not be substantiated and it did not carry the warning label required by U.S. law. Over 900 comments/signatures have been sent in to the FDA supporting petition #99P-1340.(5)

Though the FDA has not made a formal ruling on the petition, it has included in its year 2000 priorities the development of strategies to issue warnings for products formulated with ingredients for which the safety has not been established.(6)


Assertion #4: The cosmetic industry wants to explain its position on fragrances.

Rebuttal: In order for there to be any resolution of problems, the industry must be willing to do much more than state its position. It must be willing to engage in open dialogue and address health, safety, and environmental concerns. It must refrain from using diversionary tactics to shift focus from well-established concerns to controversial health topics.

Although health, safety, and environmental concerns have been raised for some time, the industry has chosen not to address these issues. Only since their profits and image have been threatened has there been any willingness to concede that fragrances can trigger health effects in some individuals.


Assertion #5: Fragranced products are well regulated.

Rebuttal: Due to trade secret status of fragranced products, regulation is extremely limited. Ingredients in the fragrance portion of the product do not have to be revealed to anyone, including regulatory agencies. Other than a handful of materials, virtually anything can be used as a raw fragrance material. Testing for safety and health effects are not required before marketing.(7,8)

U.S. law requires a warning label on products when safety has not been substantiated for all the ingredients in the final product.(7) By its own admission, the fragrance industry has tested less than half of the over 3000 raw materials in use.(8) This law is not enforced as virtually no fragrance products carry the required warning.

Canadian law requires that labels warn of any avoidable hazards associated with the product that the consumer should be aware of.(9) There are known skin sensitizers used in fragrances that can cause skin allergy. No warning of this known hazard appears on labels.

After years of work by dermatologists, new labeling requirements regarding skin sensitizers in fragranced products are imminent in Europe. The extent of this labeling requirement has not yet been determined or at least not made public. The U.S. and Canada will probably follow the European Commission's lead in labeling skin sensitizers. (10)


Assertion #6: Scented products are not the worst offenders as there are many other allergens and materials that can cause adverse effects.

Rebuttal: In order to gauge what rank an allergen has, there must first be a way of measuring this. In dermatology, fragrances rank as one of the most common allergens and the numbers of people with skin allergies to fragrance continue to rise. Given the airways and lungs are generally more susceptible than the skin to allergens, it is prudent to consider that fragrances may also rank high as respiratory allergens. There is no available testing for fragrances as respiratory allergens, so there is no way to determine whether fragrances are the worst offenders.

Until such testing is available, the only way to gauge how problematic fragrances are is by clinical and patient accounts. Fragranced products are frequently cited as triggers for asthma, allergies, and other problems. Virtually every organization and agency concerned with respiratory health list fragrances as triggers for asthma.(11,12)

Testing needs to be developed to determine which fragrance materials are respiratory allergens. Until problematic materials are pinpointed and are eliminated from use, or listed on the label, the only way to avoid exposure to problematic materials is to avoid all exposures to fragranced products.

Further, fragrances are volatile compounds that add to indoor air pollution. Indoor air quality affects everyone; and those with asthma, allergies, sinus problems, and other respiratory disorders are much more severely impacted. On the basis of air quality issues alone, restrictions on the use of fragranced products are prudent.(13)

In Nova Scotia, fragrance reduction policies are part of an over all effort to reduce exposure to indoor air pollutants of all types from numerous sources.


Assertion #7: Fragrance bans violate personal rights.

Rebuttal: Personal rights are very relative because we do not live in the world alone. When personal rights collide, there has to be an evaluation of the situation. It causes the user no harm to refrain from using a scented product. For those that have adverse reactions, such use can cause great harm. When actions by one triggers illness in another, which prevents access to work, health care, and essential services, whose rights are being violated?


Assertion #8: "Individuals freedoms are pretty quick to be removed if given half a chance by anyone who has some kind of special interest," (Charles Low, president of Canadian Cosmetic Toiletry and Fragrance Association).

Rebuttal: The only interest of those seeking to limit the use of fragranced products in public spaces is health -- hardly a "special interest." Perhaps the special interest is an industry that wishes to maintain the status quo and not have to account for the effects of the products it produces.


Assertion #9: Problems can be solved by encouraging "responsible use" of grooming products.

Rebuttal: Certainly education is a very important aspect. Before responsible use can be accomplished, responsible products must be available. Use of multiple scented products is encouraged by the industry making subtlety impossible. The same industry that says one's fragrance should not be detected more than an arm's length away produces products, which when used as directed, permeate a room for hours.

"Materials that combine high odor volume with high inherent strength are diffusive, in that they can be smelled at a great distance and are very effective at the dry-out stage". (Calkin RR, Jellinek JS. Perfumery: Practice and Principles; pages (166-167) (Wiley 1994).)

Columnist Leah Mclaren claims she deliberately applied numerous fragranced products and went to the waiting area of Halifax Children's Hospital which had a fragrance ban. This children's hospital serves many asthmatics and others affected by fragrance chemicals. There should be no debate over fragrance bans in medical facilities as health care should be accessible for all. Such actions by a few demonstrate how mean-spirited people can be. It only takes the actions of one person using fragrance to undo the efforts of many that are willing to be courteous and responsible.(14)


Assertion #10: The fragrance industry is adequately addressing health, safety, and environmental concerns.

Rebuttal: Present testing protocols are inadequate. Testing of individual raw materials do not reflect real use condition. Synergistic and modifying effects must be considered. Testing should be expanded to include respiratory, neurological and systemic effects.

There needs to be in place an industrywide means of reporting adverse reactions to fragrances with a contact number listed on labels of products. This data could then be used to pinpoint problematic products and materials. The present program, in place to help dermatologist pinpoint ingredients in products to which their patients have adverse reactions, needs to be expanded to include both other adverse effects and practitioners.

Consumers need to be educated that fragrance may trigger and exacerbate well known medical conditions such as asthma, allergies, and migraines. Labeling to this effect also needs to be included.

Products need to be formulated so they are less diffusive and intrusive to others. Functional products need to be less highly scented and more should be offered without fragrance, including masking fragrance.

Perhaps most important of all, the fragrance industry must be willing to responsibly address concerns raised. Avoiding these issues will in the long run cause great harm to the industry. With the present levels of fragrance use, problems will continue to rise. Refusal to address concerns casts great doubt on the industry's ability to regulate itself. Cooperation with those that are having adverse effects could greatly help the industry in the long run. A panel composed of people from the industry, the medical and scientific community, and of those having adverse symptoms from fragrance material needs to be formed to formally identify concerns. It is only through hard work and cooperative efforts that these complex and important issues can be resolved.


REFERENCES: 1. Calkin RR, Jellinek JS. Perfumery: Practice and Principles; pages (19-20) Wiley 1994

2. AROMA CHEMICALS AND THE FLAVOR AND FRAGRANCE INDUSTRY., Chemical Economics Handbook.) p. 503.5000 A. Laszlo P. Somogyi, Birgitta Rhomberg, Yasuhiko Sakuma

3. Fundamentals of cosmetic product safety testing; Cosmetics and Toiletries; (v111 n10) Start Page: p79(7) ISSN: 0361-4387; Romanowski, Perry Schueller, Randy

4. Petiton #99-1340 filed with the FDA by the Environmental Health Network of California

5. Petition can be viewed at: http://www.ameliaww.com/fpin/Petition.htm [or http://users.lanminds.com/~wilworks/FDApetition/bkgrinfo.htm] or http://www.fda.gov/ohrms/dockets/dailys/051199/cp00001.pdf

6. CFSAN 2000 Program Priorities: U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition February 10, 2000

7. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Cosmetics Fact Sheet February 3, 1995. "FDA Authority Over Cosmetics"

8. Nitro musks in fragrance products: an update of FDA findings.(includes related article on self-regulation by the fragrance industry) Cosmetics and Toiletries; June 1996 (v111 n6) Start Page: p73(4) ISSN: 0361-4387; Wisneski, Harris S. Havery, Donald C.

9. AVOIDABLE HAZARD - Section 24 of the Cosmetic Regulations (Food and Drugs Act) Canada

10. FRAGRANCE ALLERGY IN CONSUMERS: A REVIEW OF THE PROBLEM ANALYSIS OF THE NEED FOR APPROPRIATE CONSUMER INFORMATION AND IDENTIFICATION OF CONSUMER ALLERGENS: SCCNFP/0017/98 Final December 1999

11. American Lung Association: Asthma Magazine Article: Wheezing at Work -- The Office Can be Home to an Assortment of Asthma Triggers by: Dawn Marvin and Jackie Trovato http://www.lungusa.org/pub/ast_article4.html )

12. JAMA: What Triggers Asthma? Education and Support Center http://www.ama-assn.org/special/asthma/support/educate/triggers.htm

13. The Analysis of Perfumes and their Effect on Indoor Air Pollution By John J. Manura Presented at EAS, Somerset, NJ., November 1998)

14. Non-scents in Nova Scotia; LEAH McLAREN; The Globe and Mail; Saturday, April 29, 2000)