Frequently Asked Questions
(in progress)
The issue of fragrances having an impact on health is often a
controversial one.
These are some of the questions that are frequently asked.
- Fragrance materials have a long history of relatively safe use.
- Fragrance materials are safety tested.
- Present testing is adequate.
- The industry can adequately regulate itself to ensure the safety of fragranced products.
- Only a small segment of the population has adverse effects from fragrances.
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.
The Research Institute for Fragrance Materials (RIFM) safety tests fragrance materials.
Only about 1500 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.
Most chemical data sheets and MSDS information on fragrances materials plainly state: "The chemical, physical, and toxicological properties have not been thoroughly investigated."
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 are 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.
Versalide 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.
Perfumes and fragrances are recognized as triggers for asthma by the American Lung Association and other organizations concerned about respiratory health.
In spite of legitimate concerns, the industry does not include testing for the neurological and respiratory effects of fragrance materials.
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 being found in human fat tissue and breast milk. In spite of this the IFRA has made no restrictions or recommendations concerning its use.
1-2% of the population has skin allergies to fragrances. Fragrance is one of the most common causes of adverse reactions to cosmetics.
Asthma rates have doubled in the past twenty years. In 1994 there were over 14 million asthmatics. In one study 72% of asthmatics were triggered by perfumes and colognes. Each year over 35 million people suffer from sinusitis. Fragrances are general irritants that contribute to the incidence of sinus problems.
Migraines effect as many as 25 million people. Fragrances are known triggers for migraine headaches.
Many other health conditions are adversely affected by fragrances. Those with chronic lung disease find exposure to fragrances exacerbate their condition. Those receiving chemo-therapy for treatment of cancer often find exposures nauseating.
The safety of fragrances is a general health issue that negatively impacts many. As a self-regulating industry, the Fragrance Industry must adequately address the issues involved. If they are not willing to do this, then the FDA must do it's job and ensure that these products are safe.
How effective is fragrance industry testing?
In the book "Fragrances: Beneficial and Adverse Effects" Richard Ford (the then Vice-President of the RIFM) wrote a chapter related to the efforts of the RIFM. One of the statements made in the book follows:
"Over the approximately 30 years since its inception, RIFM
has tested virtually all important fragrance materials in
common use. (It has always been the policy of RIFM that
if a material is used by only one company, it is that
company's responsibility to see that the material is
adequately tested and evaluated.)" (Richard A. Ford,
"RIFM Activities in the Safety Assessment of the Dermal
Effects" page 184 of the book
Fragrances: Beneficial and Adverse Effects)
A closer look at that statement reveals that many
chemicals are not tested by the RIFM. It seems chemicals that are patented are not tested
until the patent expires. A material that is patented is only manufactured by the company
that owns the patent or companies that are given permission by the owning company. A
patent usually lasts for 17 years. It is usually a few more years before it is
manufactured by other companies and another few years after it is in general use before it
is evaluated by the RIFM. A material may be in use 20 - 25 years before it is evaluated by
the RIFM.
Even though a material is manufactured or controlled by one company does not mean it is
not in widespread use. The raw chemical is sold to other companies for use in their
products and are put in bases which are widely used by other companies in scenting their
products. So for 20-25 years the only testing done on a proprietary material is done by
the company that owns the patent. When the patent expires, it is usually assumed that the
material has been adequately tested and has a history of safe use. Unfortunately there is
no way in place of collecting data on specific fragrance chemicals to determine if they
are problematic. Problems are usually discovered by accident after they have already been
put into general use. Such was the case of AETT.
Acetylethyltetramethyltetralin (AETT) was a proprietary synthetic musk chemical patented
in the early 1950s. It was widely used in products of all types. In 1975 in routine tests
for irritancy, Avon made a disturbing discovery. With repeated application, it was noted
that the skin of the mice had a bluish cast and they exhibited signs of neurotoxicity.
Further investigations pinpointed AETT as the culprit. The internal organs of the mice had
turned blue and there was severe neurological damage. The myelin sheath or covering of the
nerves was damaged in a manner that is similar to that which occurs with Multiple
Sclerosis. Damage was irreversible.
The industry tested AETT for another two years before the FDA was notified in the fall of
1977. The industry "voluntarily" removed the material from use, so the FDA took
no action. There was no recall of products on the shelf or notification of the public. At
least one company continued to use the material until March 1978.
Another section of the book states:
"Additionally, the industry is continually developing new materials. The RIFM program also involves review and evaluation of such materials as they become into general use. It is generally expected, however that the company that has developed such materials will provide the necessary test data for proper evaluation" (Richard A. Ford, "RIFM Activities in the Safety Assessment of the Dermal Effects" page 188 of the book Fragrances: Beneficial and Adverse Effects)
The results of the evaluations by the RIFM are published in Food and Chemical Toxicology. In addition a cross reference list of all the materials the RIFM has evaluated has been compiled. The last evaluations by the RIFM were published in 1992. None of the proprietary chemicals introduced since 1970 are included in these evaluations. These materials are widely used in the fragrance industry and typically are present in modern formulations at relatively high levels.
"The technique that has evolved to meet the demand for this new type of perfume revolves around the use of a comparatively small number of synthetic materials, all of which tend to be long-lasting and capable of being used at very high levels, or up to 25% or more, . . . ("A New Type of Perfumery" page 139 of the book Perfumery: Practice and Principles by Robert R. Calkin & . Stephen Jellinek)
10/06/02