Industry 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 Research Institute for Fragrance Materials (RIFM) was established in 1966 to assess the safety of fragrance materials. The RIFM collects data and evaluates information available on fragrance substances. An independent board reviews this material. The data is then published in scientific journal "Food and Chemical Toxicology. At present about 1300 of the more than 5000 chemicals used in the fragrance industry has been evaluated by the RIFM.

The International Fragrance Association (IFRA) is an international organization representing fragrance manufactures. The IFRA takes toxicological data and the data collected by the RIFM and evaluates the information. From this information guidelines are for the safe use of fragrance materials are formulated. The guidelines are published as IFRA Code of Practice for use by the fragrance industry. The guidelines may recommend that certain materials not use used or safe levels of use set.

 

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.

"On any given day, a consumer may use as many as 25 different cosmetic products. If each of these products contains 10 different ingredients, this consumer could easily be exposed to more than 200 different chemical compounds."

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

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.


 

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. 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 fragrances 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)

*These articles are available online for a fee from the "Northern Lights" site

 


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