Fragrances are not safe

Industry Answers Fall Short

Follows is a point by point discussion of the answers the industry provided in the article, Fragrances, are they safe published in the Nov/Dec issue of Flavour and Fragrance Journal. Excerpts from the article are in quotes.

"A completely adequate mechanism exists for ensuring the safety evaluation of fragrance materials"

There is a self-regulatory process for evaluating the safety of fragrance materials. However, this process falls far short of being adequate. There is often no independent testing as data is obtained from the manufacture. Testing is done on individual chemicals rather than mixtures that are common in fragrance formulas. And testing is not done via all routes of exposure. The process has no outside review. Often the communication between self-regulatory organizations are private with no independent assessment.

"The fragrance industry has taken the approach of 'primary prevention' (i.e. restricting the use of the most widely acknowledged allergenic fragrance materials).

Testing of allergenic potential is done by patch testing high levels of fragrance chemicals on volunteers on a short-term basis. Though exposure is considerably higher than actual fragrance exposures, it is not a realistic evaluation of allergenic potential. Repeated long-term exposure seems to be an important factor in development of skin allergies, this is not reflected in industry testing methods. Care is taken to ensure similar materials are not on the same test panel as it causes more positive reactions. Known skin sensitizers continue to be used. Fragrance formulas often contain several known sensitizers, which are at times at higher levels than recommended.

"There are also unsubstantiated reports that major fragrance chemicals such as limonene, as well as very minor ones such as benzaldehyde and even substances not used at all in fragrances, such as toluene are respiratory sensitizers. Indeed, no single fragrance material is listed anywhere as, or known to be, a respiratory sensitizer"

While limonene itself is not a respiratory sensitizer, the breakdown products of limonene are respiratory sensitizers. While it is possible to limit the breakdown of limonene with the use of antioxidants, it can not be eliminated. Once in the air, it is subject to breakdown and formation of respiratory sensitizers.

There are materials used in fragrance that are listed as and known to be respiratory sensitizers. Both beta-ionone and alpha-ionone are on the EU list Perfume and Aromatic Raw Materials and are known to be respiratory sensitizers according to MSDS sheets from Aldrich Chemical Company. Pine rosen is listed on the EU list of list Perfume and Aromatic Raw Materials. It is known to be a respiratory sensitizer.

Toluene is a not a direct fragrance chemical. It is one of the major starting materials for synthesis of fragrance chemicals. Toluene may be present in fragrance chemicals as a contaminate from synthesis of fragrance chemical. Fragrance chemicals are often unstable and may breakdown. So toluene may be the breakdown product of fragrance chemicals synthesized from toluene.

Further fragrance chemicals are not routinely tested for respiratory effects. The industry had no protocol to determine if fragrance chemicals are respiratory allergens. So the truth is it is not known if most fragrance chemicals are respiratory sensitizers or not.

Respiratory sensitization is not the only way fragrance chemicals can affect the respiratory system. Many fragrance materials are respiratory irritants. Irritants can cause underlying inflammation, swelling, and increased mucus production of the upper airways and lungs. They can cause increased susceptibility to allergens, toxins, and infections. Those with asthma and respiratory problems are especially sensitive to irritants and levels tolerated by others may cause asthma attacks.

"The fragrance industry, through IFRA, has a clear policy banning the use of neurotoxic materials in fragrance. It is committed to eliminating substances that have been experiementally shown to be neurotoxic (even if such effects were only observed at exposure levels well above those likely to be encountered by consumers in any conceivable exposure scenario). The International Fragrance Association promptly banned acetyl ethyl tetramethyl tetralin (AETT) and musk ambrette as soon as toxicity studies in animals identified the effect."

AETT was in use for over 20 years before it was voluntarily banned by the IFRA. Musk ambrette had been in use for over 60 years before it was voluntarily banned by the IFRA. Musk ambrette continued to be found in perfumes on the shelf, years after the voluntary ban by the industry. While there may be a policy to ban the use of neurotoxic materials, there is no policy on testing for neurotoxic effects. In spite of the experience with AETT and musk ambrette, testing for neurological effects is still not a part of routine evaluation for safety of fragrance chemicals.

There is a growing body of evidence that indicates fragrance chemicals can cause autonomic nervous system effects and alter blood pressure, pulse, and mood. This is via pharmacological action, not psychological effects.

"The discovery of the more lipophilic fragrance materials in (albeit low) steady-state levels in human adipose tissue and mothers'milk has prompted the fragrance industry to carry out extensive safety testing programmes, which have permitted the authorities to give preliminary favourable opinions."

The "preliminary favourable" refers to the European Union's assessment of two polycyclic musks, AHTN and HHCB. The EU recommended that exposure to musk ketone and musk xylene be cut in half of present levels of exposures in cosmetics. Further, long term toxicity studies were recommended. The recommendations only took into account cosmetic exposures. These musk compounds are frequently used in cleaners and laundry products and that exposure needs to be assessed. In the US, both musk ketone and musk xylene are more frequently used than in Europe.

When human breast cancer cells were exposed to musk ketone and musk xylene, there was an increased growth rate of the cells. Both materials tested positive for estrogenic effects. Musk xylene has been found to be carcinogenic in animal studies and musk ketone increased the carcinogenic effects of other materials. Both of these nitromusks bioaccumulate in human tissue and are found in mother's milk. It is also likely that these materials cross the placental barrier.

"Similarly, recent concerns over phthalates relate to members of this chemical family which are not principally used as fragrance materials. The diethyl ester is a major fragrance ingredient, but has been recently judged to present no danger to health under current conditions of use in cosmetic products."

Perhaps the judgment was premature, a recent study suggests there is a link between diethyl phthalate and sperm damage.

"The fragrance industry deals in relatively small quantities of materials. For this reason, it has until recently not been a focus of attention regarding environmental effects."

The quantities are not so small. When scented products are considered collectively, they represent a tremendous exposure to both people and the environment. And the awareness that fragrance chemicals contaminate the environment is not really new. Japan banned nitromusks because of concerns that surfaced in the early 1980s. Why has it taken 20 years for the fragrance industry to focus their attention on these concerns?