Self-Regulation

The fragrance industry is essentially a self-regulated one.(1) Perfumes, cosmetics, and many personal care products come under the jurisdiction of the FDA. Due to "trade secret" status of fragrance formulas the actual authority over fragrances is very limited.(2) There are certain labeling requirements specified by law. Legally there are a handful of chemicals that are banned from use.(3)

There is no pre-approval process for the use of fragrance materials in products. There are several organizations within the industry that address the issues of safety of fragrance materials. While these organizations can make recommendations, they are not legally binding.

The Cosmetic, Toiletry, and Fragrance Association (CTFA) is the leading U.S. trade association for the personal care products industry. It was founded in 1894 to protect the freedom of the industry to compete in a fair and responsible marketplace. The CTFA assesses the safety of cosmetics via various programs. It has in place a program to help dermatologist determine specific allergens, including fragrance in a product. Other than this one program, the CTFA has not been involved in testing and evaluation of materials in the fragrance portion of products.

Faced with increasing concerns related to fragrance safety and possible regulation, the fragrance industry developed a system of self-regulation. This self-regulatory system is composed of the Research Institute for Fragrance Materials (RIFM) and the International Fragrance Association (IFRA).

RIFM was founded in 1966 by the industry to carry out research on ingredients used in fragrances and assure the safety of perfumery materials. Approximately 1,300 materials, less than half of the over 3000 in use,  have been evaluated by the RIFM. Monographs on these substances have been published in Food and Chemical Toxicology (formerly Food and Cosmetic Toxicology).

The RIFM Board of Directors is elected from chief executive officers from member companies. The research portion of the Institute is separate from the administrative part. The president serves on both administrative and research branches. A Scientific Advisory Board composed of perfumers, researchers, and chemists from the fragrance industry advises the president and determines which materials are to be assessed. The RIFM gathers data from testing, information provided by manufactures, and information from published studies. The data obtained is then evaluated by an independent panel composed of toxicologists, pharmacologists, and dermatologists from outside the fragrance industry.

The RIFM only evaluates individual raw materials and not combinations of materials used in final products. It is the responsibility of the manufacture to ensure that finished products have been properly evaluated for safety.

The results of the screening of these materials are submitted to the International Fragrance Association. The IFRA then evaluates the data and formulates guidelines for safe use of the materials. The IFRA has made recommendations on about 70 fragrance chemicals. Some of these materials should not be used in fragrances, while others can be used if levels are limited.

The IFRA publishes their recommendations or Code of Practice and makes it available in printed form or at their web site. The IFRA has no authority to enforce the recommendations. Companies that do not follow them can be expelled from the organization. To date no company has been expelled and there is no monitoring to ensure recommendations are followed.

Effectiveness of Self Regulation

An industry that regulates itself in a responsible manner is the ideal situation. However, there are often inherent problems and limitations to this self-regulation. There is tremendous potential for looking out for the short-term interests of the industry rather than the long term interests of the consumer. Also these are recommendations and not regulations. They are not legally binding.

The track record of safety evaluations has been questionable. The safety testing has been limited and does not cover all routes of exposure. For the most part only safety of individual materials have been considered and not the effects of combinations.

AETT was found to cause serious neurological problems in rodents in a study conducted in 1977. The monograph previously published in "Food and Chemical Toxicology" did not pinpoint any problems with the safety of this chemical. Once this was discovered the material was quietly withdrawn from use in fragrances. The material had been in common use as a fragrance material for more than 20 years.

Musk ambrette causes severe phototoxicity problems. It has also been found to be neurotoxic. The IFRA recommends that Musk ambrette not be used in products that are applied to the skin. Again the original monograph published in "Food and Chemical Toxicology" did not pinpoint any major problems with the safety of this chemical. Even after it was recommended that musk ambrette not be used in skin contact products, it took almost five years before it was eliminated from use in cosmetics.

Many of these hundreds of chemicals have had very little safety testing. This is of concern, not just for the people using them, but also for others that are exposed and the environment. Musk xylene has found it's way into the food chain. These synthetic musk chemicals are not filtered out through waste water treatment and are being found in the water supply. Synthetic fragrance chemicals are being found in human fat tissue and breast milk. (5) The significance of this is not known since there have been very few studies done on the safety of these synthetic musks.

Even with the IFRA guidelines there is nothing binding companies to follow them. So called "Natural" based products have been found to have above the recommended levels of some fragrance materials. This greatly increases the risk of sensitization and other adverse effects. Some of these materials were synthetic rather than natural, which also brings into question labeling practices. (6)

There are many questions about the safety of fragrance chemicals and fragranced products that the industry has not provided the answers for. With the increases in fragranced products there are increased exposures. And with increased exposures there are more problems and more people are affected. Safety issues extend far beyond the user of the products. For the fragrance industry to remain a self-regulated one, these issues have to be addressed in a responsible manner.

For more information see the section on Industry

References: (Return takes you back to the point in the text that you exited)

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

2. FDA : Authority over cosmetics (Return)

3. FDA: Prohibited Ingredients (Return)

4. Fundamentals of cosmetic product safety testing. Cosmetics and Toiletries Oct 1996 (v111 n10) Start Page: p79(7) Romanowski, Perry; Schueller,Randy (Return)

5. Polycyclic musk fragrance in human adipose tissue and human milk. Chemosphere. 1996 Nov; 33(10): 2033-2043. Rimkus GG, et al. (Return)

6. Natural ingredients based cosmetics. Content of selected fragrance sensitizers. Contact Dermatitis. 1996 Jun; 34(6): 423-426. Rastogi SC, et al. (Return)