the aromaconnection blog

Essential oils cool planet

by Robert Tisserand

It now appears that the world would have warmed more than it has were it not for the aromatic cocktail of chemicals emitted by plants. It turns out that this can change the weather – and anything that changes the weather day after day and year after year changes the climate too. While this mechanism is nowhere near strong enough to save us from global warming, it may have been stronger in the past when the air was cleaner. So could it be that Gaia is not powerless after all? Stephen Battersby

It has long been suspected that the envelope of essential oil vapor around an aromatic plant helps protect it from extremes of temperature, especially heat. It makes sense that higher temps lead to greater essential oil evaporation, and this in turn has a cooling effect on the plant (evaporation from a surface is always cooling). Until recently, no one imagined that there might be a cooling phenomenon taking place on a much larger scale.

There is always invisible water in the ambient air. There are also tiny particles floating in the air, such as salt and dust; these are called aerosols. The water vapor and aerosols are constantly bumping into each other. When the air is cooled, some of the water vapor sticks to the aerosols when they collide – this is condensation. Eventually, bigger water droplets form around the aerosol particles, and these clump together with other droplets, forming clouds.

The Gaia hypothesis
The Gaia hypothesis is James Lovelock’s idea that the planet as a whole is capable of environmental self-regulation (Lovelock & Margulis 1974). In 1987, Lovelock and others proposed a feedback mechanism that could counterbalance global warming involving the oceans. Called the CLAW (after its authors) hypothesis, this proposed that algae in the sea emit a gas called dimethyl sulfoxide, which can react with air to form sulfuric acid vapor and condense into aerosols (Charleson et al 1987). Warmer weather causes greater algal growth, and the aerosols could feasibly cool the planet by reflecting sun directly, and also indirectly by making clouds whiter. However, water droplets do not form and grow unless they are at least 100 nanometers in size, and models of the CLAW hypothesis later showed that particles would not reach even close to this size. In addition not enough dimethyl sulfoxide is released to make a difference.

In 2004, scientists at the University of Helsinki proposed an alternative model involving pine trees instead of algae (Kulmala et al 2004). They hypothesized that increased temperatures and atmospheric CO2 would lead to increased photosynthesis and forest growth, leading to an increase in pine oil emissions. Pine oil is mostly composed of monoterpenes such as limonene and pinene. These terpenes rise above the trees, and combine with sulphur dioxide and other aerosols to form especially large cloud droplets. Clouds with larger droplets are whiter, reflecting more sunlight back into space, cooling the land below, and thus counteracting the effects of global warming. (More trees also means more CO2 absorption, so there is a double benefit.) Even if forest growth did not increase, in warmer weather, pine trees emit significantly more essential oil (Fuentes et al 2000).

Global warming offset
This hypothesis now looks like a reality – not so much in terms of increased forest growth, but warmer temperatures do result in greater pine oil emissions, which do cause whiter and larger clouds. A research team at Manchester University has demonstrated that, as aerosols and water accumulate, the presence of terpenes changes the chemistry of the drops, allowing them to attract more water, and this can substantially increase the  number of droplets (Topping et al 2013). A cloud with a greater concentration of droplets is a whiter, fluffier cloud.

The clincher comes from a study involving 11 weather stations around the planet. A team including Markku Kulmala and Paul Paasonen, also at Helsinki, sampled the air at these stations, counting the number of aerosols of 100 nanometeres or larger, and also the level of terpenes. They found a clear pattern (Paasonen et al 2013). The effect is strongest in places such as eastern Siberia and Finland, where the air is clean. “But in more polluted areas, the feedback is not significant” says Paasonen.

The extent of the effect is not known, but it may not be very big. It could offset global warming by as much as 10%, or it might be less than 1%. And, where there is significant atmospheric pollution, pine oil evaporation makes no difference. But it’s one reason to preserve existing pine forests, and also applies to spruce, larch and similar species. Russia, Scandinavia and Canada take note. In theory, it will also apply to any large plantation of aromatic plants, but in reality pine forests may be the only significant contributor because of their mass.

Footnote
The terpenes are only able to contribute to cloud formation because, once in the atmosphere, they are oxidized by ozone and other gases into slightly larger particles, and this is an important step in the process. So more ozone could also lead to whiter, larger clouds, again supporting the Gaia hypothesis. This is somewhat ironic because high ozone at ground level also oxidizes these terpenes, which of course come from essential oils too, and inhaling the resulting oxidation products can cause respiratory problems. So what is good for the planet above tree level is not so good for people with respiratory problems below. Fortunately, this only happens where there are high ozone levels.

References
Battersby S 2013 Call in the Clouds. New Scientist issue 2923: 32-35http://www.newscientist.com/article/mg21829231.900

Charlson RJ, Lovelock JE, Andreae MO, Warren G 1987 Oceanic phytoplankton, atmospheric sulphur, cloud albedo and climate. Nature 326 (6114): 655–661doi:10.1038/326655a0

Fuentes JD, Lerdau M, Atkinson R et al 2000 Biogenic hydrocarbons in the atmospheric boundary layer: a review. Bulletin of the American Meteorological Society 81: 1537-1575http://nature.berkeley.edu/biometlab/espm228/Fuentes%20et%20al%20BAMS%202000.pdf

Kulmala M, Suni T, Lehtinen KR et al 2004 A new feedback mechanism linking forests, aerosols, and climate. Atmospheric Chemistry & Physics 4: 557-562http://hal.archives-ouvertes.fr/docs/00/29/54/16/PDF/acp-4-557-2004.pdf

Lovelock JE, Margulis, L 1974 Atmospheric homeostasis by and for the biosphere: the Gaia hypothesis. Tellus Series A 26: 2–10http://www.gps.caltech.edu/classes/ge148c/pdf%20files/lovelock.pdf

Paasonen P, Asmi A, Petaja T et al 2013 Warming-induced increase in aerosol number concentration likely to moderate climate change. Nature Geoscience 6: 438-442http://www.nature.com/ngeo/journal/v6/n6/full/ngeo1800.html

Topping D, Connolly P, McFiggans G 2013 Cloud droplet number enhanced by co-condensation of organic vapours. Nature Geoscience 6: 443-446http://www.nature.com/ngeo/journal/v6/n6/full/ngeo1809.html

Robert Tisserand is internationally recognized for his pioneering work in many aspects of aromatherapy since 1969 and frequent contributor to the aromaconnection blog.

AGORA moves to a new index site

AGORA is the Aromatherapy Global Online Research Archive. It was formed in 1998 by a group of aromatherapists who wrote articles about aromatherapy and essential oils, and was hosted at a number of different websites, including www.naturesgift.com, www.wingedseed.com, and others, with an index to all the articles hosted on a now dead site: users.erols.com/sisakson/pages/agoindex.htm (no, don’t try to go there because it is not there now).

Sometime in the middle of the last decade, the owner of the index, Suki, lost control of the index site when its host was sold and she moved to a new ISP. But mysteriously, the index continued to function and had about 2,000 entries in a Google search. It still gets 651 hits.

I was the original technical administrator of the site, although the individual host site owners did their own local administration. Over the years, as the original authors left the world of aromatherapy, many of the articles needed updating, link maintenance, and upkeep. I eventually contacted Suki to see if we could update the index page. That was when I discovered that no one had access to it. I knew that eventually it would disappear, so I captured a copy of the index and several other pages on that site to my computer. When the site died, I decided to set up a new index site. This took me some time as many other pages had to be recovered from the Web using the Wayback Machine and reformatted  and moved to the new site. I actually accomplished that about a year ago, but have been too busy to actually get it publicized and correct the site links in to it that will help build it back up as a viable site. I realized last week that the aromaconnection blog’s link to AGORA had never been updated.  That has now been done. So here are the links to the new site.

The new AGORA Index site is at http://www.AGORAIndex.org/ which takes you to an introductory page.  The actual Index page is http://www.AGORAIndex.org/agoindex.htm

There is also a twitter feed @AGORAAroma where I occasionally post links to the AGORA site.

Please check out the site, link to the index page, and tweet about it. that will help improve its SEO ratings and get more people visiting it.

Technorati Tags: users.erols.com/sisakson/pages/agoindex.htm,AGORAIndex,AGORA,Aromatherapy Global Online Reseach Archive,Essential Oils,Aromatherapy Information

Ingredient obsession

by Robert Tisserand

I am not against transparency in labeling. I think it’s a subject that could use a lot of discussion. But I am against ingredient obsession. In a society that allows alcohol, tobacco and firearms to be freely purchased, and that turns a blind eye to the widespread use of illegal drugs, why are we concerned about whether a consumer product might contain a few parts per million of chemical X? Should we not be concerned, rather about whether the product itself is safe?

Ingredient tunnel vision is seriously bad for your health. It will turn you into an obsessive, paranoid, vicious, spitting fireball of righteous indignation. You will write searing blog posts, develop gastritis or worse, lose sleep, and die young. And for what? Essential oils and their constituent chemicals are very frequent targets. Because essential oils contain chemicals, and because almost all chemicals are, to some people, toxic by definition, many bloggers in the green movement have become anti-fragrance and anti-essential oils. For a while I though that, when they realize that linalool is found in lavender oil, and that limonene is in lemon oil, they will relent. I was wrong. Obsession is, in fact, relent-less. It allows no release, no vacation, no light side. It is all-consuming!

Because essential oils are alleged to contain “allergens”, they are also favorite targets of regulators and legislators, especially in Europe. And, we in North America know full well that whatever happens in Europe must be good, because Europeans are more intelligent. Their accents prove this. Since I have been living in the US (12 years now) my accent has slowly become less English English, and more American English, and my mental faculitoes have detturiated protortionisely, as you kan see.

Peer-not
More on Europe soon. But first, a new study financed by Silent Spring Institute, written by Robin Dodson et al, and published in Environmental Health Perspectives. EHP claims to be peer-reviewed, but if this report is anything to go by, its reviewers need replacing. In fact, they might as well not bother with peering, since it clearly accomplished nothing. The report is entitled: Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products. Classes of chemicals that were tested for include UV filters, cyclosiloxanes, glycol ethers, parabens, phthalates, alkylphenols and fragrances. The “fragrances” tested for include these essential oil constituents:

For your edification, I have highlighted one essential oil and also some foods that naturally contain said chemical. No rationale is given for why these particular substances were selected. This is important, not only because they have now become what might be called “target chemicals of concern”, but because the list could have been so much longer. It could include almost every essential oil constituent in existence. Now, at a rough guess, this is in the region of 1,000. The above list is said to represent “asthma-related chemicals”. This is not defined anywhere, but the article begins with “Laboratory and human studies raise concerns about endocrine disruption and asthma from exposure to chemicals in consumer products” and it goes on to talk about “asthma-related chemicals.”

Fragrance chemicals do not cause asthma, but they can exacerbate asthmatic symptoms. Many fragrance chemicals have this potential because they are very mild respiratory irritants in concentration. It’s the nature of the beast. However, listing limonene, isobornyl acetate, terpineol etc., is not helpful. If you are asthmatic, and you tend to react badly to fragrances, then you stay away from fragrances. Mounting a new campaign to list particular fragrance ingredients on consumer labels will not accomplish anything. It will not meaningfully make fragrances safer, and if consumers need a warning that a product is fragranced, this can be accomplished in either one word: “FRAGRANCE”. Or two: “CONTAINS FRAGRANCE”.

The paper states that, if a compound is “available from plant materials”, it was described as natural, and if “commonly synthesized”, then it was described as synthetic. But there is no list! No classification! So we don’t know which they regard as natural, and which as synthetic! In the text, limonene is mentioned as being natural (correct), isobornyl acetate as synthetic (incorrect) and hexyl cinnamaldehyde as natural (incorrect, since it is always synthesized. It is also spelled wrongly throughout the article. I’m Just saying…).

No direct evidence is provided for any adverse health effects for any of these compounds, and there is no discussion of the factors involved, although several papers are cited: “Fragrances, particularly terpenes such as limonene, are associated with secondary chemical reactions in indoor air, and can contribute to the production of formaldehyde, glycol ethers, ultrafine particles, and secondary organic aerosols (Nazaroff and Weschler 2004; Singer et al. 2006). Exposure to fragrances has been associated with a range of health effects, including allergic contact dermatitis, asthma and asthmatic exacerbations, headaches, and mucosal symptoms (Heydorn et al. 2003; Kumar et al. 1995; Steinemann 2009).”

Dodson and friends do not mention that moderate-to-high levels of ozone are required for these reactions to take place, nor that cleaning products (which can also contain volatiles such as formaldehyde, benzene, toluene and xylene) are the only ones that have been reported to cause actual health problems (Nazaroff and Weschler 2004). Ozone-limonene reactions can produce hydroxyl radicals, and these in turn can contribute to formaldehyde formation (Fan et al 2003). However, this was only observed under conditions that were admitted to be not typical of “nonindustrial indoor environments.” And, the statement that terpenes such as limonene can contribute to the formation of glycol ethers is not true. Nazaroff and Weschler (2004) state that both terpenes and glycol ethers were found in some cleaning products, not that one is formed from the other! And while I’m on my soapbox,, ultrafine particles and secondary organic aerosols are the same thing. Now, if I can find this many holes in a research paper without breaking a sweat, where is the so-called “peer-review”? And how much credence can we give any of the findings?

The Kumar et al (1995) study did find exacerbation of respiratory symptoms in asthma patients when they smelled perfume scent strips, as used in magazine advertising. And other research shows that if you give asthma patients strong fragrances to inhale, they may react adversely. The same is true for people with multiple chemical sensitivity, but it is not true of the general population.

Under extreme conditions terpenes such as limonene and pinene do form particles that are respiratory irritants. These conditions require (a) moderate-to-high ozone, and (b) substantial quantities of vaporized terpenes. These may be hazardous for vulnerable individuals, such as babies, older people, or people with asthma. However, it’s a leap to assume that fragrances cause health problems. They don’t. Yes, a fragrance could trigger an asthma attack in a person with asthma. But it cannot cause asthma. In a mostly supportive Forbes blog post based on Dodson’s article, Amy Westervelt quotes the following lines:

“This study presents a clear example of biased, advocacy-based research,” says William Troy, Ph.D., Scientific Advisor the International Fragrance Association North America. “It is a repackaging of older information and the methodology used defies basic principles and standards of scientific protocols and investigations. The advice to consumers based on study findings is simply wrong,” said Dr. Troy.

“There’s been a lot of work done on exposure to these chemicals in average households, and we know that these chemicals are found in air and dust in peoples’ homes, and the CDC [Center for Disease Control] has shown that we find them in our bodies as well,” says the study’s lead author Dr. Robin Dodson. “Now we’re trying to understand where the chemicals are coming from, and how people are exposed to them.”

There is a degree of naivete in this last statement. As far as the fragrant compounds are concerned, they are naturally found in some common foods (see Table), so that could be one reason that they are found in our bodies. Limonene and pinene are ubiquitous simply because so many trees produce them. If you have pine furniture, it is giving off limonene and pinene vapors. If you have paint thinned with turpentine, same deal, because turpentine is made from pine trees. If you live near trees…basically, if you’re breathing, you are inhaling limonene and pinene. How much you are inhaling, what the ambient ozone level is, and whether or not you have asthma are all considerations in whether these vapors might present a hazard. Some advice:

• If you are asthmatic, beware of strong fragrances.
• In high-ozone conditions (usually hot weather combined with factory exhalations and/or much vehicular traffic) beware of exposure to high levels of fragrant molecules.
• When using cleaning products, paints, glues or varnishes, ventilation is important.
• Note that some types of office equipment, such as photocopiers and fax machines, give off ozone.

Dodson advises avoiding fragranced products, and looking for ones with plant-based ingredients. So would that include or exclude essential oils? I’m baffled.

References
Dodson R, Nishioka M, Standley LJ et al 2012 Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products.

Fan Z, Lioy P, Weschler C et al 2003 Ozone-initiated reactions with mixtures of volatile organic compounds under simulated indoor conditions. Environmental Science & Technology 37:1811-1821

Heydorn S, Johansen JD, Andersen KE et al. 2003 Fragrance allergy in patients with hand eczema – a clinical study. Contact Dermatitis 48:317-323

Kumar P, Caradonna-Graham VM, Gupta S et al 1995 Inhalation challenge effects of perfume scent strips in patients with asthma. Annals of Allergy Asthma & Immunology 75:429-433

Nazaroff WW, Weschler CJ 2004 Cleaning products and air fresheners: exposure to primary and secondary air pollutants. Atmospheric Environment 38:2841-2865

Steinemann AC 2009 Fragranced consumer products and undisclosed ingredients. Environmental Impact Assessment Review 29:32-38

Robert Tisserand is internationally recognized for his pioneering work in many aspects of aromatherapy since 1969 and frequent contributor to the aromaconnection blog.

Negative Bias

by Robert Tisserand

Safety legislation does not always accord with current knowledge on safety, for the simple reason that new scientific data are always being published. Guidelines are periodically made more stringent, but they are almost never loosened, even when new information suggests it. Regulators don’t like to admit that they were wrong, and this is especially true of the European Union. In the United States, although the FDA has few regulations that directly restrict cosmetic ingredients, most manufacturers, especially the larger ones, follow both IFRA guidelines and EU regulations. Taken together, these result in some extremely stringent measures for essential oils.

The reason that US manufacturers follow EU guidelines is because, if they sell internationally, they use one formulation that works in all regions – multiple formulations are uneconomic. And, although IFRA guidelines are technically a voluntary code, they are very widely adhered to for two reasons. One, almost all

large cosmetics manufacturers are full members of IFRA, and as such they formally agree to follow the IFRA code. Two, even non-members want to be sure they are manufacturing safe products, plus they don’t want to risk the possible legal ramifications of not adhering to industry best-practice guidelines. IFRA recently put out a video called Making Scents, which you can find here.

In spite of all this, some North American consumer groups are concerned that many personal care products contain ingredients that are highly toxic, and that are banned in Europe. There are particular concerns about fragrances, which are said to contain chemicals that are hormone disrupting, neurotoxic, teratogenic or

Coriandrum sativum

carcinogenic. The fact that fragrance ingredients are not declared on labels feeds the perception of hidden toxins lurking. However, these concerns are often misplaced. For example, fears of neurotoxicity may be inappropriately based on the results of toxicity testing, in which the signs and symptoms of a fatal dose are noted. And, concerns about skin allergy are sometimes based on results that, when closely examined, do not represent a significant risk for consumer products.

There is a growing hysteria about “chemicals” in consumer products, as if the fact of a substance being a chemical made it inherently toxic. It is understandable that consumers do not know the difference between a synthetic chemical and a naturally-occurring one. (Synthetic chemicals, while not necessarily more toxic, are less environmentally friendly.) However, even the Environmental Working Group appears not to know which essential oils contain which chemical constituents.

The European Union “allergens”
In 2003, the European Union’s Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) published a directive listing 26 fragrance materials as skin allergens (SCCNFP 1999). One of the criteria listed was that “Positive patch test data from more than one patient in more than one independent centre should be present.” In other words, a substance could be listed as an allergen if there were two or more reports of skin allergy. Even if these two reports occurred over, say, 20 years. Several papers have since been published strongly suggesting that many of the 26 fragrance materials should not be listed as allergens at all. The EU has done nothing but dig its heels in.

Linalool is one of the EU “allergens”. If present in a cosmetic product at over 100 ppm (0.01%) in a wash-off product or 10 ppm (0.001%) in a leave-on product, linalool must be declared on the ingredient list if sold in an EU member state. Doesn’t sound too bad, does it? The problem is, neither manufacturers nor retailers want to get sued, or branded as selling unsafe products, and most retailers will only carry cosmetics that have passed an independent safety assessment, which is almost entirely based on looking at the levels of “allergens”. So the de facto result is that very few manufacturers take the risk of having a “known allergen” in a product at over the declarable amount.

Linalool is a major constituent of some commonly-used essential oils and is found in approximately 200 other essential oils. But linalool is not a high-risk allergen. In fact, it’s superlatively safe on the skin. Between 1969 and 2007 (38 years), a total of thirteen dermatitis patients out of the 25,164 tested, (0.05%) were allergic to linalool when patch tested, and less than this actually had allergic reactions to products containing linalool (De Groot 1987, De Groot et al 2000, Fregert and Hjorth 1969, Frosch et al 1995, Itoh et al 1986, Santucci et al 1987, Schnuch et al 2007). Yes, 0.05% is more than zero, but it’s pretty close to the 0.03% reaction rate for petrolatum, the least dermally allergenic substance known to mankind. One way of looking at this is that adding linalool to a product increases risk by about 0.02%. That’s probably less than almost any other known cosmetic ingredient.

But, this assumes that patch testing reflects real-world risk, which it does not, in fact it is designed to exaggerate risk. It does this in two ways. One, patches are non-permeable, and are left adhered to the skin for 48 hours. Two, the concentrations used in testing are higher than those encountered in personal care products. Linalool is tested at a 5%, 10% or 20% dilution. Since skin allergies are dilution-dependent, lower dilution will carry less risk. There is no dermatological or other scientific rationale that suggests extrapolating data from a 10% dilution to a safety threshold of 0.001% – 10,000 times less! Quite the opposite – the clinical data suggest that a 10% concentration of linalool in cosmetics is virtually non-allergenic. When tested at 5% on a total of 1,399 dermatology patients, linalool produced not one single allergic reaction (Frosch et al 1995, Itoh et al 1986, Santucci et al 1987).

The EU listed linalool as an allergen because – according to their own report – five dermatitis patients had allergic reactions to it over a five-year period on patch testing. Considering that linalool is (or at least used to be) one of the most commonly-used fragrance materials, an average of one reported adverse reaction per year, on planet earth, is about a negligible as it is possible to get. But, this still does not represent actual risk to consumers, which is likely much lower.

Data from Schnuch et al 2007

Of the 26 EU “allergens”, 16 are essential oil constituents and two are absolutes. In 2007, these were each tested on groups of 2,000 or more dermatology patients. Of the 16, six produced so few adverse reactions that the report concluded that they should not be classed as allergens at all. Benzyl benzoate, for example, produced not a single adverse reaction in 2,003 patients (Schnuch et al 2007). The other non-allergenic constituents are linalool, limonene, benzyl alcohol, benzyl salicylate and anisyl alcohol, and other dermatologists have questioned the classification of linalool and anisyl alcohol as allergens (Gilpin and Maibach 2010, Hostýnek and Maibach 2003a). Other research has shown that adverse reactions to coumarin are due to impurities present in the synthetic coumarin used for testing, and that 99% pure coumarin is not allergenic (Vocanson et al 2006, 2007). And, Hostýnek and Maibach (2003b) argue that the evidence for farnesol being an allergen is highly debatable. If we add farnesol and coumarin to the list of spurious allergens, then 50% of the EU 16 are a mistake.

These voices of dissent are not insignificant, and include some of the most distinguished dermatologists in the world. They question whether the patch test information is “clinically relevant”, and whether it can be extrapolated to estimate risk in the general population. Certainly, the percentages in the Table above under “% of patients reacting” do not represent real-world risk, and for many of these substances there is not a single case of skin reaction that has been proven to be caused by the substance in question. What these numbers do suggest is the relative potency between the different substances. Or at least, it would if they had all been tested at the same % concentration. And just to be clear, the division into three groups by Schnuch et al is theirs, not mine.

The David Suzuki Foundation
Paradoxically, EU cosmetics legislation is frequently cited in North America as an example of what cosmetics legislation should look like. In Canada for example, the David Suzuki Foundation (DSF), an environmental activist group, has this message for their supporters: “Consumers have the right to know about all ingredients contained in cosmetics – including fragrance chemicals. European regulations are stronger. They require 26 sensitizers used as cosmetic fragrances to be identified on the label. That’s a start, and it’s better than what we have in Canada.”

The DSF says that their mission is “to protect the diversity of nature” but the European legislation unfairly targets the farmers that grow the plants that produce the essential oils that contain the chemicals that David Suzuki wants to see identified on labels, a move which will inevitably lead to further restriction. I am not opposed to the principal of ingredient declaration for fragrances, and I applaud those manufacturers that have already made this move. However, I believe that if a product contains lavender oil, this should be declared as “lavender oil”, and the 70 or so constituents of lavender oil should not have to be listed. I have already argued here against the idea that constituents of ingredients should be declared on cosmetic labels.

The Environmental Working Group
The Environmental Working Group (EWG) is a US-based organization that calls even more stridently for increased legislation of fragrance ingredients. Fragrances, we are told, contain chemicals that are neurotoxic, teratogenic, carcinogenic and hormone disrupting.

On its Skin Deep database, the EWG bases hazard ratings of essential oil constituents largely on the flawed EU legislation. The EWG makes no reference to the dissenting voices in the scientific community, either because it is unaware of such dissent, or because it chooses to ignore it. The EWG is not a regulatory body, nor does it publish safety guidelines, it simply labels a cosmetic ingredient with a number from 0 to 10, with 10 being the most hazardous. It does give some explanation for how this number is arrived at, but no specific recommendations are made. Skin Deep gives linalool a hazard rating of 4. However, Aniba rosaeodora (Rosewood) oil, which contains 82-90% linalool, has a hazard rating of 0-1. Coriander seed oil, which contains 59-88% linalool, has a hazard rating of 1. These hazard ratings seem to be inconsistent.

Skin Deep, at least, is consistent in its inconsistency. Limonene has a hazard rating of 6, and yet lemon oil (57-76% limonene) has a hazard rating of 0, and sweet orange oil (84-96% limonene) a hazard rating of 1. Safrole (a rodent carcinogen) is given a hazard rating of 7, while sassafras oil (83-90% safrole) is given a hazard rating of 0. Sassafras oil contains more safrole than any other essential oil. Some other carcinogens found in essential oils, asarone and estragole for instance, are not even mentioned on the Skin Deep database. Pulegone is a hepatotoxic compound found in pennyroyal oil. In spite of this, both the compound and the essential oil are rated as 0. Go figure.

Fragrance
If you look at “Fragrance” on the EWG’s Skin Deep database, you will see that it has a rating of 8. This applies to any fragrance at all, and 11,376 products are listed. This seems more like a declaration of war on the personal care products industry than a genuine safety guideline! And note that “fragrance” is rated as far more hazardous than either sassafras oil (a known carcinogen) or pennyroyal oil (a known hepatotoxin). The principal reasons given for the high rating for fragrance are:

Allergies & immunotoxicity
Miscellaneous
Neurotoxicity
Data gaps

It’s worth taking a closer look at the Skin Deep rationale:

Allergies & immunotoxicity
This is further defined as “linked to immunotoxicity, or harm to the immune system, a class of health problems that manifest as allergic reactions or an impaired capacity to fight disease and repair damaged tissues in the body.” Perfume is then cited as a “known human immune system toxicant”, and a single reference is given: SCCNFP 1999. This is the opinion paper that eventually became a legal directive in 2003.

Since this is a 63 page document, there is insufficient space here to dissect it in detail. To pick one simple fact, the document concerns 24 fragrance ingredients that, it is recommended, should be restricted in consumer products because they are potential contact allergens (oakmoss absolute and treemoss absolute were added later). This is to say, 24 of the estimated 3,000 existing fragrance ingredients, or 0.8%. To conclude from this that all fragrances present a high, or even a moderate risk of skin allergy is negative bias, because it is not based on real-world risk.

Returning to the Skin Deep wording, something is amiss. A single reference is given for skin allergy, but no supporting evidence is cited for immunotoxicity, which is a much more serious hazard. This could be viewed as a deliberate manipulation of words and/or facts in order to mislead and suggest negative information that does not exist. Skin allergy is indeed a sub-category of immunotoxicity, but the principal meaning of the word – causing damage to the immune system – does not apply. But, because Skin Deep couches these terms together “Allergy/Immunotoxicity”, and because it has – quite correctly – defined immunotoxicity as damage to the immune system, any substance that can cause skin allergy is also flagged by implication, as reducing your capacity to fight disease, which is something totally different. Since there is no evidence of immunotoxicity, apart from skin allergy, this looks like negative bias again.

Miscellaneous
This is defined as “ingredient not fully labeled – identity unknown”. Indeed, fragrance is not a single ingredient, and the great majority of fragranced products do not fully declare their fragrant ingredients. This has been a subject of debate for some time, and is a reasonable criticism in terms of transparency. However, it is not, per se, any kind of risk assessment or toxicity rating, it is simply a fact, an observation.

Neurotoxicity
This is defined as “Linked to neurotoxicity, or harm to the brain and nervous system, a class of health problems that can range from subtle developmental delays to chronic nerve degeneration diseases.” One reference is given, which is said to provide “moderate evidence” of neurotoxicity. The reference is: USHR (U.S. House of Representatives), 1986. Neurotoxins: At Home and the Workplace. Report by the Committee on Science & Technology, Report 99-827. Sept 16 1986. In this report it is claimed that over 95% of chemicals used in fragrances are synthetic compounds derived from petroleum, including benzene derivatives, aldehydes and other toxins and sensitizers capable of causing cancer, birth defects central nervous system disorders and allergic reactions.

The report is not a scientific study, and so what we have is nothing but hearsay. Somebody said/wrote something, so the “has been linked to” is satisfied! All fragrances have now “been linked to” neurotoxicity. This is a very serious charge. Note that the EWG claim is that they “provide additional information on personal care product ingredients from the published scientific literature.” Not always it seems. And note that ALL FRAGRANCE is flagged as being “linked to” neurotoxicity. “Benzene derivatives, aldehydes and other toxins and sensitizers” is, by the way, an interesting choice of words in itself, since it implies that all the benzene derivatives and/or aldehydes used in fragrances are toxic and/or skin sensitizing. This is simply not true.

Data gaps
This is explained as “not assessed for safety in cosmetics by industry panel.” This cryptic statement is odd to say the least. The implication is that no fragrance-related organization has assessed “fragrance” for safety in cosmetics. It seems that Skin Deep are unfamiliar with an organization called IFRA – the International Fragrance Association – that has been assessing fragrance for safety in consumer products for some 40 years. IFRA has many fragrance-related safety standards. That’s pretty much all they do. In my opinion, IFRA standards are often over-reaching and too stringent.  So, what exactly is meant by “Data gaps” for fragrance is, well, anyone’s guess.

At the end of the Skin Deep page on Fragrance is some useful information: “1,452 studies in PubMed science library may include information on the toxicity of this chemical” And then there is a link to PubMed. These are the search criteria: (”FRAGRANCE”[TW] OR “FRAGRANCE”[TW] OR “PARFUM”[TW] ) AND (*toxic* OR cosmet* OR derm* OR irritation OR sensiti* OR “personal care products” OR skin OR gavage OR mutagen* OR carcinogen* OR “biological activity”). Fine, great, useful, practical. What I really don’t get though, is why these 1,452 research papers are listed under the heading “Data gaps”. Isn’t this actually quite a lot of information?

Perhaps the Skin Deep approach is: “if you won’t tell us what’s in your fragrances, then we’re going to assume the worst”. But, since there’s very little evidence that fragrance causes any real harm anyway, assuming the worst involves some academic acrobatics that are shameful and not worthy of scientific credibility. Insinuation, implication and “has been linked to” is not evidence of anything, and the liberal use of this tactic shows negative bias.

Linalool: a narcotic?
A Google search for “Linalool: a narcotic” comes up with 19,200 hits. This is because the following piece of advice about a well-known fabric softener and dryer sheet fragrance is repeated that many times:

* Ethanol: On the EPA’s Hazardous Waste list and can cause central nervous system disorders.
* Limonene: Suspected Gastrointestinal or Liver Toxicant, Immunotoxicant, Kidney Toxicant, Neurotoxicant, Respiratory Toxicant, and Skin or Sense Organ Toxicant.
* A-Terpineol: Can cause respiratory problems, including fatal edema, and central nervous system damage.
* Ethyl Acetate: A narcotic on the EPA’s Hazardous Waste list.
* Camphor: Causes central nervous system disorders.
* Chloroform: Neurotoxic, anesthetic and carcinogenic.
* Linalool: A narcotic that causes central nervous system disorders.

I’m not going to go into the validity of every single claim made here, but I will tell you that most of it is either incorrect or highly misleading. Ethanol for example, known to most of us simply as alcohol, can of course cause CNS disorders if you drink enough of it. But in a dryer sheet? Are you kidding? Some of the sites that include the above information go into more detail on linalool:

LINALOOL Narcotic. Causes CNS disorders. …”respiratory disturbances” …”Attracts bees.” “In animal tests: ataxic gait, reduced spontaneous\motor activity and depression …depressed heart activity …development of respiratory disturbances leading to death.”

This information is entirely derived from LD50 testing of linalool (Jenner et al 1964, Letizia et al 2003). This is the classic test to find the single lethal dose for any substance. Rats and mice are most commonly used, and the dose cited is the one that is lethal to 50% of the animals. When you give a mammal a fatal dose of a substance it is not unusual to see some adverse effects on the nervous system, such as staggering, difficulty breathing etc., nor is it surprising if there are “respiratory disturbances leading to death.” Ataxic (unsteady) gait is probably mentioned in a majority of all LD50 test results. The oral LD50 values for linalool range from 2.2 to 3.9 g/kg, which is equivalent to an average adult human drinking 154 – 270 g (5.4 – 9.5 oz). In one of the studies, a non-fatal dose of linalool had a sedative effect on mice when injected into the abdomen at 178 mg/kg, and impaired muscle co-ordination (Atanassova-Shopova et al 1973). This is equivalent to a human dose of 12.5 mL, or 0.44 oz.

None of this means that your dryer sheets are going to kill you or your family. Nor will they cause you to faint, sway, fall over, lose control of your muscles, or otherwise behave as if drunk or dying. If you have multiple chemical sensitivity you may react adversely to any fragrance material, but not necessarily because that substance is itself inherently toxic. Unless you are in the habit of either drinking linalool by the cupful or injecting half an ounce of it into your abdomen, you may safely ignore these dire warnings, which have absolutely no relevance to the use of linalool in cosmetic or household products.

Conclusions
At least as far as essential oils are concerned, the EWG database reveals a shocking degree of ineptitude. They seem to have no idea which essential oils contain which constituents, and they only know about legal restrictions, which they automatically support 100%. If the EU says that linalool is a skin allergen, then it must be right. The EWG staff don’t seem to have read most of the toxicological literature, which they simply give a PubMed link to, and throw this in under “Data gaps”! They are just tossing out information hoping that some of it will stick. There is no science-based risk assessment, and the hazard ratings don’t tell you how much (or how little) of a substance is safe.

The EWG has helped stir up considerable hysteria about cosmetic safety. Increasingly, we see articles, blog posts and videos put out by people who are repeating misinformation and who often have no idea what they are talking about. That this should lead to the targeting of essential oil constituents is highly ironic, considering the very real healing benefits that they have to offer – from skin cancer prevention, to the treatment of antibiotic-resistant infections. And it is happening because of ignorance. We seem to entering a new Dark Age, where truth is measured by Google hit numbers, and scientific fact no longer counts for anything. In some cases safety legislation, instead of reflecting the science, is usurping and replacing it. Another irony is how EU cosmetics legislation is regarded in North America with something approaching reverence while in Europe it is regarded as, at worst, a Nazi-based tyranny (I’m not making this up – there’s quite a conspiracy theory…) and at best, a major hassle.

References
Atanassova-Shopova S, Roussinov KS, Boycheva I 1973 On certain central neurotropic effects of lavender essential oil. II communication: studies on the effects of linalool and of terpineol. Bulletin of the Institute of Physiology, Bulgarian Academy of Sciences 15:149-156

De Groot, AC 1987 Contact allergy to cosmetics: causative ingredients. Contact Dermatitis 17:26-34

De Groot AC, Coenraads PJ, Bruynzeel DP et al 2000 Routine patch testing with fragrance chemicals in the Netherlands. Contact Dermatitis 42:184-185.

Fregert S, Hjorth N 1969 Results of standard patch tests with substances abandoned. Contact Dermatitis Newsletter 5:85

Frosch PJ, Pilz B, Andersen KE et al 1995 Patch testing with fragrances: results of a multicenter study of the European Environmental & Contact Dermatitis Research Group with 48 frequently used constituents of perfumes. Contact Dermatitis 33:333-342

Gilpin S, Maibach H 2010 Allergic contact dermatitis from farnesol: clinical relevance. Cutaneous & Ocular Toxicology 29:278-287

Hostýnek JJ, Maibach HI 2003a Is there evidence that anisyl alcohol causes allergic contact dermatitis? Exogenous Dermatology 2:230-233

Hostýnek JJ, Maibach HI 2003b Is there evidence that linalool causes allergic contact dermatitis? Exogenous Dermatology 2:223-229

Itoh M, Ishihara M, Hosono K et al 1986 Results of patch tests conducted between 1978 and 1985 using cosmetic ingredients. Skin Research 28(Suppl.2):110-119

Jenner PM, Hagan EC, Taylor JM et al 1964 Food flavorings and compounds of related structure I. Acute oral toxicity. Food & Cosmetics Toxicology 2:327-343

Letizia CS, Cocchiara J, Lalko J et al 2003 Fragrance material review on linalool. Food & Chemical Toxicology 41:943-964

Santucci B, Cristaudo A, Cannistraci C et al 1987 Contact dermatitis to fragrances. Contact Dermatitis 16:93-95

SCCNFP 1999 Opinion concerning fragrance allergy in consumers: a review of the problem. SCCNFP/0017/98 Final

Schnuch A, Uter W, Geier J et al 2007 Sensitization to 26 fragrances to be labelled according to current European regulation. Results of the IVDK and review of the literature. Contact Dermatitis 57:1-10

Vocanson M, Goujon C, Chabeau G et al 2006 The skin allergenic properties of chemicals may depend on contaminants – evidence from studies on coumarin. International Archives of Allergy & Immunology 140:231-238

Vocanson M, Valeyrie M, Rozières A et al 2007 Lack of evidence for allergenic properties of coumarin in a fragrance allergy mouse model. Contact Dermatitis 57:361-364

Robert Tisserand is internationally recognized for his pioneering work in many aspects of aromatherapy since 1969 and frequent contributor to the aromaconnection blog.

Agro Forestry Tree Database

If you are looking for detailed information about essential oils and related products that are derived from trees, you need to know about the Agro Forestry Tree Database. I’ve added it to our list of databases on the right sidebar.

I’ve linked to the home page, which has search facilities so you can type in the name of a plant and get detailed information about Species identity, Ecology and Distribution, Propagation and management, functional uses, pests and diseases, additional information, a bibliography, and images of the tree.

The information provided is much more detailed than the summarized data that appears in Wikipedia, and probably has much more authority.

The web site also provides a downloadable copy of the data base and and downloadable desktop tool to map the range of the plants.

Aromatics in Print

The February-April 2011 issue of Herbalgram (#89) arrived recently, with several items of aromatic interest.  Since this is the current issue some of the articles in the online version require a subscription for web access. I will provide links to the free articles.

• The Herb Profile in this issue is Sage (Salvia officinalis). This is a complete profile that provides detailed information about the herb, and plant, the history and cultural significance, and modern research. Most of the research presented involves the essential oil, including studies of its effect on memory, cognition and mood, with some studies on the physical effects, including sore throat treatment, anti-inflammatory effects, and Herpes simplex infection.  There is also a discussion of current production and sustainability potential, although the data available are admitted to be minimal.
• A detailed article describes “The Plant List: The first Comprehensive Inventory of Most Known Plant Species”, available online only by subscription. However, if you are interested in seeing the actual list, you can link to it here at The Plant List. The list is an attempt to standardize the Latin binomial names of all plants. It lists over 1 million plant names of species rank; 298,900 are accepted species names. This list should go a long way towards standardizing the names of aromatic plant species, although it will not resolve the question of INCI names that have been derived through a separate process.
• An article reports on the recent COP (Conference of the Parties) meeting for the Convention on Biological Diversity (CBD) which met last October in Nagoya, Japan. (Registration required) Click this link if you want to see the actual COP/CBD website.
• A major article reports on “The Safety of Bitter Orange (Citrus aurantium) and p-Synephrine.” This article is in response to previous reports in Consumer Reports that have suggested that Bitter Orange is unsafe as a dietary supplement. The article deals with this use and does not mention the essential oil at all. The article thoroughly debunks the safety concerns about internal use of “Bitter Orange Extract” and attributes the concerns to erroneous information released by the FDA. Since the concerns were with internal use, it would seem unlikely that the use of bitter orange oil in aromatherapy would be of concern other than its well-known phototoxic effects. Tisserand/Balacs in Essential Oil Safety rate its Oral Toxicity as D, or non-toxic. I attempted to determine if the ingredient of concern (p-Synephrine) is present in the essential oil. The best study I found online (Toxicological Summary for Bitter Orange . . .) suggests  that the essential oil doesn’t contain any of the alkaloids they studied [“Oils from the fruit, peel, and other plant parts are also used for flavoring and fragrance and do not contain alkaloids.” Curiously, that study doesn’t seem to have been cited in the Herbalgram article.
• A major article “The Genus Ligusticum in North America” is available on the web only by registration. Since Samara Botane has in the past sold “Medicine Root” essential oil (which is Ligusticum canbyi –an unresolved name per the Plant List) I was particularly interested in this article, which is mainly about “Osha” root, and the confusion of the various Ligusticum species that are confused with it. These plants are members of the “Lovage” family which is found throughout the world. The article contains a list of the phytochemicals found in the various species, and shows their distribution throughout North America.

As usual, Herbalgram, the Journal of the American Botanical Council, provides a plethora of information about herbal issues related to the aromatic industry, and is well worth a subscription.

Technorati Tags: Aromatics in Print,Essential Oils/Plant Extractions,Safety/Toxicity

The Safe Cosmetics Act 2010

by Robert Tisserand

The Safe Cosmetics Act of 2010 (SCA 2010), now before the House of Representatives, is an inappropriate and seriously flawed attempt to make cosmetics safer. You can read the full text here. The thinking behind it is identical to a bill that was proposed (and defeated on March 1st this year) in Colorado (see Tunnel vision). Both are the brainchild of a group including the Campaign for Safe Cosmetics (SFSC) and the Environmental Working Group (EWG) which are in turn linked to the Skin Deep database. SCA 2010 is being opposed by groups representing small businesses such as Opposesca.com, the Indie Beauty Network and Personal Care Truth which also reflects the views of many cosmetic chemists. A petition opposing SCA 2010 can be found here.

SCA 2010 is unscientific, unworkable, and if passed as is, would likely cause widespread job loss in the cosmetics industry. Far from being a step in the right direction, it would be a leap into regulatory chaos, as well as targeting small businesses and natural products.

Yes, cosmetics could and should be safer, and cosmetics labeling in the USA does need more transparency. Safety can always be improved in any field, especially in the light of new scientific data, but SCA 2010 over-reaches what is needed to such an extent that, with the possible exception of distilled water, I cannot think of any cosmetic ingredient that would be acceptable under its terms.

These require that there is “data demonstrating that exposure to all sources of the ingredient or cosmetic present not more than 1 in a million risk for any adverse effect in the population of concern”. Unfortunately, “population of concern” is not defined, but SCA 2010 further states that, in establishing a safety standard, “no harm will be caused by aggregate exposure for a member of a vulnerable population to that ingredient or cosmetic.” “Vulnerable populations” are defined, and include “pregnant women, infants, children, the elderly, and people with compromised immune systems.” Would “infants” include pre-term babies? Would “people with compromised immune systems” include those who do not get sufficient sleep, or who suffer from frequent colds? Much of the wording of the bill is vague and open to many possible interpretations.

“Ingredient” includes every substance present in an ingredient “at levels above technically feasible detection limits.” This last phrase is not defined, but it could be as low as one part per billion (ppb, 0.0000001%) or one part per trillion (ppt, 0.0000000001%). SCA 2010 specifically mentions contaminants, and in foods and beverages they are commonly measured at these levels.

Most essential oils contain about 100 constituents. The above data – for example no more than 1 in a million risk – must be demonstrable for each one of these constituents. Otherwise, the essential oil may not be acceptable in cosmetics, according to the terms of the bill. I can think of of no substance, natural or synthetic, that is known to cause no adverse reaction of any kind in less than 1 in a million people. In human tests for skin reactions, there are sometimes data covering tens of thousands of patch tests. But, that’s still a long way from a million, and there is no cosmetic ingredient that, if patch tested on one million people, would cause no more than one reaction. Except for distilled water perhaps.

“Any adverse effect” is not defined, but is not as simple as it might seem. Linalool, for example, has caused CNS depression when inhaled by animals. (Alcohol is the classic CNS depressant – in large enough amounts, it causes loss of muscular control, slurred speech, stupor and other effects.) Linalool is one of the most common constituents of fragrant herbs and flowers, inhalation of which could therefore be regarded as hazardous under the vague terms of SCA 2010. In reality, linalool has no more than a mild calming, anti-anxiety effect when inhaled by humans. It’s one of the main constituents of lavender oil.

The issue of dose and concentration is not given much consideration. “The Secretary shall presume that any ingredient or cosmetic that induces cancer or birth defects or has reproductive or developmental toxicity when ingested by, inhaled by, or dermally applied to a human or an animal has failed to meet the safety standard.” This is a complete reinvention of the science of toxicology, which up until now has been based on the principle of dose and of threshold levels. Above certain amounts toxicity may occur, below them it will not. This is why there are permissible levels for substances such as hydrocyanic acid (”cyanide”, restricted to 1 ppm) which naturally occurs in some foods.

There’s also the question of the interaction between the constituents of a natural substance. Basil herb, for example, contains two known carcinogens – estragole and methyleugenol. Pesto is a particularly concentrated form of basil, yet the WHO has determined that the amounts in basil/pesto are so small that they present no risk to humans. Since that ruling, research has been published demonstrating that basil herb contains anticarcinogenic substances that counter any potential toxicity of the two carcinogens, and is itself anticarcinogenic (Alhusainy et al 2010, Dasgupta et al 2004, Jeurissen et al 2008). Some basil essential oils have been shown to have anticarcinogenic effects (Aruna & Sivaramakrishnan 1996, Manosroi et al 2005).

Probable or known human carcinogens, such as acetaldehyde and benzo[a]pyrene (BaP) are ubiquitous in fruits, vegetables, dairy products, meat and fish at low ppb. I’m not saying this is a good thing, I’m just saying it’s a fact, and these foods are not regarded as dangerous, because the toxins are present in such minuscule amounts. BaP is one of the many carcinogens found in cigarette smoke, but it is also found in American drinking water at 0.2-2.0 ppb, and in olive oil at about 3 ppb. Olive oil is actually anticarcinogenic, because of its content of antioxidant polyphenols, squalene, β-sitosterol and linoleic acid (Sotiroudis & Kyrtopoulos 2008). It’s the same story with fruits and vegetables – they are generally anticarcinogenic due to a very much higher content of antitoxic substances.

Many essential oils, herb extracts and foods contain tiny amounts of single constituents that alone, and in substantial amounts, are known to be toxic, but the parent natural substance is not toxic. However, this scenario is not taken into consideration by the CFSC or EWG. These organizations are, wittingly or unwittingly, campaigning to have natural substances banned from use in cosmetics because of their “tunnel vision”  and “parts per billion” approach to safety.

The thinking behind the wording of SCA 2010 is naive because there is an assumption that substances are either “safe” or “toxic”, and that if we simply eliminate the toxic ones from personal care products, the world will be a better place. It may seem like an excellent idea, but once you start talking about parts per million or lower, it is unnecessary and unrealistic. Not even foods are regulated to that degree, and our exposure to foods is far greater than our exposure to cosmetics.

SCA 2010 requires that every constituent or trace contaminant of every ingredient be listed onthe product label. This arguably discriminates against natural products, since their ingredient lists would have to include hundreds of substances, if they could be proved to be safe under the terms of the bill, and if there was some way of actually listing that many ingredients on a label. A product containing what would normally would be regarded as five ingredients – olive oil, blue chamomile extract, and essential oils of orange, rose and vetiver – would require an ingredient list looking something like this:

oleic acid, palmitic acid, stearic acid, linoleic acid, linolenic acid, squalene, hydroxytyrosol, tyrosol, oleuropein, ligstroside, elenolic acid, acetoxy-pinoresenol, oleocanthal, α-tocopherol, herniarin, hyperoside, umbelliferone, methylumbelliferone, caffeic acid, chlorogenic acid, quercetin, rutin, flavanone, isorhamnetin, quercimeritin, anthemic acid, choline, triacontane, patuletin, patulitrin, apigetrin, apigenin-7-glucoside, apigenin-7-apiosylglucoside, luteolin-7-glucoside, apigetrin-7-acetylglucoside, luteolin-4-glucoside, luteolin, patuletin, matricin, matricarin, galacturonic acid, d-limonene, citronellol, geraniol, myrcene, linalool, α-pinene, sabinene, β-phellandrene, geranial, neral, decanal, citronellal, (Z)-β-ocimene, β-pinene, valencene, β-elemene, terpinolene, dodecanal, γ-terpinene, β-sinensal, α-sinensal, δ-cadinene, α-copaene, γ-muurolene, nerol, δ-3-carene, (Z)-3-hexenol, perillaldehyde, octanol, cis-sabinene hydrate, undecanal, nonadecane, heneicosane, 1-nonadecene, 2-phenylethanol, (E)-β-ocimene, methyleugenol, eugenol, 1-heptadecene, eicosane, trans-linalool oxide, β-caryophyllene, 1-tricosene, α-terpineol, α-farnesene, farnesyl acetate, citronellyl formate, pentadecane, α-guiaiene, benzaldehyde, (Z)-β-farnesene, terpinen-4-ol, geranyl acetate, isogeranyl acetate, farnesyl propionate, methyl salicylate, citronellyl acetate, hexanol, α-humulene, methyl geranate, α-terpinene, cis-rose oxide, isogeraniol, β-bergamotene, δ-2-carene, cis-linalool oxide, octadecane, heptadecane, α-phellandrene, cis-rose oxide, β-maaliene, ethyl benzoate, geranyl acetone, 3-methylbutanol, docosane, 1-heneicosene, p-cymene, 1-eicosene, bourbonene, γ-cadinene, hexadecane, 1-tricosene, octanal, nerolidol, 2-undecanone, benzyl benzoate, α-muurolene, 2-phenylethyl phenylacetate, farnesol, geranyl formate, guaiol, heptanal, allo-ocimene, 1-octadecene, 2-phenylethyl-3-methyl valerate, hexadecanol, hexanal, 3-hexenyl formate, 2-phenylethyl benzoate, khusimol, vetiselinenol, cyclocopacamphan-12-ol (epimer A), α-cadinol, α-vetivone, β-vetivenene, β-eudesmol, β-vetivone, khusenic acid, β-vetispirene, γ-vetivenene, α-amorphene, (E)-eudesm-4(15),7-dien-12-ol, β-calacorene, (Z)-eudesm-6-en-11-ol, γ-amorphene ziza-5-en-12-ol, β-selinene, (Z)-eudesma-6,11-diene, salvial-4(14)-en-1-one, khusinol, cyclocopacamphan-12-ol (epimer B), selina-6-en-4-ol, khusian-ol, δ-amorphene, 1-epicubenol, khusimene, ziza-6(13)-en-3β-ol, ziza-6(13)-en-3-one, 2-epi-ziza-6(13)-en-3α-ol, 12-nor-ziza-6(13)-en-2β-ol, α-vetispirene, eremophila-1(10),7(11)-diene, dimethyl-6,7-bicyclo-[4.4.0]-deca-10-en-one, 10-epi-γ-eudesmol, α-calacorene, (E)-opposita-4(15),7(11)-dien12-ol, prekhusenic acid, 13-nor-eudesma-4,6-dien-11-one, isovalencenol, spirovetiva-1(10),7(11)-diene, 2-epi-ziza-6(13)-en-12-al, (E)-isovalencenal, preziza-7(15)-ene, (Z)-eudesma-6,11-dien-3β-ol, intermedeol, isoeugenol, isokhusenic acid, elemol, eremophila-1(10),6-dien-12-al, juniper camphor, khusimone, eremophila-1(10),4(15)-dien-2α-ol, eremophila-1(10),7(11)-dien-2β-ol, (Z)-isovalencenal, allo-khusiol, methyl-(E)-eremophila-1(10),7(11)-dien-12-ether, (E)-2-nor-zizaene, (Z)-eudesm-6-en-12-al, funebran-15-al

No contaminants have been shown here, only natural constituents of the five ingredients. Whether this list of 200 chemicals would be useful for consumers is debatable, and it would be one of the shorter lists, since most natural products contain much more than five ingredients. Even single synthetic chemicals are not really single chemicals at all – they also contain some minor and trace constituents. Most fragrance chemicals for example are about 95% pure, the other 5% consisting of “impurities” which of course would have to be listed. So synthetic chemicals are not exempt from this challenge.

This is one of the reasons that a naturally-occurring chemical is not the same as a synthetic one – the impurities present in the synthetic version. Synthetic coumarin, for example, causes skin allergies because of the impurities it contains (Vocanson 2006, 2007). But, SCA 2010 treats all chemicals of the same name as equal, which may be expedient if you are trying to pass legislation, but it’s not really scientific.

SCA 2010 proposes that hundreds of ingredients should be assessed for safety in unrealistically short amounts of time, with no proposal as to what form this assessment process will take, who will undertake the work, and exactly what criteria will be used. The wording of the bill shows very little understanding of either toxicology or cosmetics science. It also assumes that any existing legislation in other countries must be good legislation, when in fact nothing could be further from the truth.

I happen to believe that incremental legislation is generally a good thing. It at least allows for the possibility of public debate, and for finer points to be properly considered. Legislation as sweeping as SCA 2010 will cause chaos in the cosmetics industry, especially since States will be given the option to add further safety standards as they see fit. So, each State could have different standards – a manufacturer’s nightmare, and a pointless provision. Even without it, how any agency could enforce legislation involving hundreds of thousands of existing products, with hundreds of ingredients to consider for each one is mind-boggling.

SCA 2010 will cost unknown millions or billions of dollars which the consumer will ultimately pay for. It will probably have no more than a negligible effect on cosmetics safety, but it poses a serious threat to many businesses especially those making natural products, those supplying natural ingredients, and the farmers that grow the plants they come from.

SCA 2010 is especially onerous to small businesses (any corporation with a turnover of $7 million or less.) It requires each manufacturer to not only declare every constituent chemical of every ingredient on the label, but to also test each finished cosmetic to ensure that there is not even a trace amount of some toxic chemical that might have been formed during the making of the product. Most small personal care product businesses will not survive if SCA 2010 passes, a fact that may possibly be attractive to larger corporations.

However, the bill has been criticised by Lezlee Westine, President and CEO of the Personal Care Products Council, which represents the larger cosmetics companies. Her statement includes the following: “We are concerned that the Safe Cosmetics Act of 2010 as written is not based on credible and established scientific principles, would put an enormous if not impossible burden on FDA, and would create a mammoth new regulatory structure for cosmetics, parts of which would far exceed that of any other FDA-regulated product category including food or drugs. The measures the bill would mandate are likely unachievable even with the addition of hundreds of additional FDA scientists and millions more in funding and would not make a meaningful contribution to product safety.”

The Skin Deep database, mentioned in the first paragraph, gives an insight into the thinking of the CFSC and EWG. Skin Deep exaggerates toxicity by being selective in its reporting. For example, limonene, the major constituent of citrus essential oils, is flagged as being developmentally toxic in large doses. This is true, since when pregnant mice were fed 2,363 mg/kg limonene by stomach tube on days 7-12 of gestation, there was an increase in the number of fetuses with skeletal anomalies and delayed ossification (Kodama et al 1977).

However, what is not stated by Skin Deep is that in the same report, when pregnant mice were given a lower dose, 591 mg/kg/day, there was no developmental toxicity. The higher dose is equivalent to daily human ingestion of 5.7 oz of limonene, and the lower dose is equivalent to 1.4 oz. If ingestion of 1.4 oz per day for 6 days is known to be non-fetotoxic, then there is no reason to believe that the use of limonene in cosmetics is likely to be in any way hazardous during pregnancy; in fact, quite the opposite (especially since stomach tube feeding generally increases toxicity).

The Skin Deep page on limonene also mentions, under “cancer” that“one or more tests on mammalian cells show positive mutation results.” One reference is given. However, this ignores the fact that eleven other studies found no evidence of mutagenicity or genotoxicity for limonene (Anderson et al 1990, Connor et al 1985, Florin et al 1980, Haworth et al 1983, Myhr et al 1990, Pienta 1980, Sasaki et al 1989, Sekihashi et al 2002, Turner et al 2001, Watabe et al 1980, 1981), and two further studies reported antimutagenic effects (De Oliveira et al 1997, Kim et al 2001). This 13:1 “score” is part of the weight of evidence used to assess risk in toxicology.

Mutagenicity testing is used to identify substances that may be carcinogenic. However, 85% of substances that are not in fact carcinogenic test positive in a least one mutagenicity test (Kirkland et al 2005). These are “false positives”, and present no risk. The one study cited by Skin Deep for limonene is a false positive.

If you want to imply risk, it’s possible to do so simply by being selective about which facts you choose to report. Many small cosmetics manufacturers have become disenchanted with the manipulative ways of the CFSC and EWG. If they were sincere in caring about cosmetics safety they would welcome any pertinent opinions and facts, but they don’t. They either ignore or stridently oppose anything that does not accord with their fear-driven political agenda. It’s a shame, because a few of their concerns are genuine and well-founded, but their focus has become highly distorted.

I urge you to oppose the Safe Cosmetics Act 2010. Here are some steps you can take.

References

Alhusainy W, Paini A, Punt A et al 2010 Identification of nevadensin as an important herb-based constituent inhibiting estragole bioactivation and physiology-based biokinetic modeling of its possible in vivo effect. Toxicology & Applied Pharmacology 245:179-190

Anderson BE, Zeiger E, Shelby MD et al 1990 Chromosome aberration and sister chromatid exchange test results with 42 chemicals. Environmental & Molecular Mutagenesis 16(Suppl. 18):55-137

Aruna K, Sivaramakrishnan VM 1996 Anticarcinogenic effects of the essential oils from cumin, poppy and basil. Phytotherapy Research 10:577-580

Connor TH, Theiss JC, Hanna HA et al 1985 Genotoxicity of organic chemicals frequently found in the air of mobile homes. Toxicology Letters 25:33-40

Dasgupta T, Rao AR, Yadava PK 2004 Chemomodulatory efficacy of basil leaf (Ocimum basilicum) on drug metabolizing and antioxidant enzymes, and on carcinogen-induced skin and forestomach papillomagenesis. Phytomedicine 11:139-151

De Oliveira AC, Ribeiro-Pinto LF, Paumgartten FJ 1997 In vitro inhibition of CYP2B1 monooxygenase by b-myrcene and other monoterpenoid compounds. Toxicology Letters 92:39-46

Florin I, Rutberg L, Curvall M et al 1980 Screening of tobacco smoke constituents for mutagenicity using the Ames test. Toxicology 15:219-232

Haworth S, Lawlor T, Mortelmans K et al 1983 Salmonella mutagenicity test results for 250 chemicals. Environmental Mutagenesis 5:3-38

Jeurissen SM, Punt A, Delatour T et al 2008 Basil extract inhibits the sulfotransferase mediated formation of DNA adducts of the procarcinogen 1′-hydroxyestragole by rat and human liver S9 homogenates and in HepG2 human hepatoma cells. Food & Chemical Toxicology 46:2296-2302

Kim MH, Chung WT, Kim YK et al 2001 The effect of the oil of Agastache rugosa O. Kuntze and three of its components on human cancer cell lines. Journal of Essential Oil Research 13:214-218

Kirkland D, Aardema M, Henderson L et al 2005 Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens I. Sensitivity, specificity and relative predictivity. Mutation Research 584:1-256

Kodama, R, Okubo A, Araki E et al 1977 Studies on d-limonene as a gallstone solubilizer (VII). Effects on development of mouse fetuses and offspring. Oyo Yakuri 13:863-873

Manosroi J, Dhumtanom P, Manosroi A 2005 Anti-proliferative activity of essential oil extracted from Thai medicinal plants on KB and P388 cell lines. Cancer Letters 235:114-120

Myhr B, McGregor D, Bowers L et al 1990 L5178Y Mouse lymphoma cell mutation assay results with 41 compounds. Environmental & Molecular Mutagenesis 16(Suppl 18):138-167

Pienta R J 1980 Evaluation and relevance of the Syrian hamster embryo cell system. Applied Methods in Oncology 3:149-169

Sasaki YF, Imanishi H, Ohta T et al 1989 Modifying effects of components of plant essence on the induction of sister-chromatid exchanges in cultured Chinese hamster ovary cells. Mutation Research 226:103-110

Sekihashi A, Yamamoto A, Matsumura Y et al 2002 Comparative investigation of multiple organs of mice and rats in the comet assay. Mutation Research 517:53-74

Sotiroudis TG, Kyrtopoulos SA 2008 Anticarcinogenic compounds of olive oil and related biomarkers. European Journal of Nutrition 47:69-72

Turner SD, Tinwell H, Piegorsch W et al 2001 The male rat carcinogens limonene and sodium saccharin are not mutagenic to male Big Blue rats. Mutagenesis 16:329-332

Vocanson M, Goujon C, Chabeau G et al 2006 The skin allergenic properties of chemicals may depend on contaminants – evidence from studies on coumarin. International Archives of Allergy & Immunology 140:231-238

Vocanson M, Valeyrie M, Rozières A et al 2007 Lack of evidence for allergenic properties of coumarin in a fragrance allergy mouse model. Contact Dermatitis 57:361-364

Watabe T, Hiratsuka A, Isobe M et al 1980 Metabolism of d-limonene by hepatic microsomes to non-mutagenic epoxides toward Salmonella typhimurium. Biochemical Pharmacology 29:1068-1071

Watabe T, Hiratsuka A, Ozawa N et al 1981 A comparative study on the metabolism of d-limonene and 4-vinylcyclohex-1-ene by hepatic microsomes. Xenobiotica 11(5):333-344

Robert Tisserand is internationally recognised for his pioneering work in many aspects of aromatherapy since 1969.

Advice for Aromatherapists and Natural Perfumers re: H.R. 5786 Safe Cosmetics Act 2010

You may think if you are a natural perfumer,  aromatherapist, massage therapist, or other alternative practitioner using essential oils or other raw botanical extracts or materials in your practice, craft or art,  that this bill will not directly affect you. At least you don’t think so.  However, you could be dead wrong.  If you are not a licensed doctor (M.D. or D.O. have the broadest authority) who can legally write a prescription, then you may be at risk under H.R. 5786 if you make essential oil blends or synergies for your clients or natural perfumes sold to clients (the general public). Thus far, essential oils have not been legally designated as either prescription or over-the-counter drugs.  The definition most used is, “A volatile oil, usually having the characteristic odor or flavor of the plant from which it is obtained, used to make perfumes and flavorings.”  In other words, they are manufacturing ingredients.

In H.R. 5786 (subchapter B), the definition of ‘ingredient’ reads:

“The term ‘ingredient’ means a chemical in a cosmetic, including - -
(A)  chemicals that provide a technical or functional effect;
(B)  chemicals that have no technical or functional effect in the cosmetic but are present by reason of having been added to a cosmetic during the processing of such cosmetic;
(C)  processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetics;
(D)  substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect;
(E)  contaminants present at levels above technically feasible detection limits;
(F)  contaminants that may leach from container materials or form via reactions over the shelf life of a cosmetic and that may be present at levels above technically feasible detection limits;
(G)  the components of a fragrance, flavor, or preservative declared individually by their appropriate label names; and
(H)  any individual components of a botanical, petroleum-derived, animal-derived, or other ingredient that the Secretary determines to be considered an ingredient. 

It is probably worth your while to ponder these definitions and take in their full impact.

Here in Washington state, the definition of ‘manufacturing’ in the state revenue code (RCW) reads:

"Manufacturer" means every person who, either directly or by contracting with others for the necessary labor or mechanical services, manufactures for sale or for commercial or industrial use from his or her own materials or ingredients any articles, substances or commodities.” (RCW 82.04.110)

"To manufacture" embraces all activities of a commercial or industrial nature where labor or skill is applied, by hand or machinery, to materials so that as a result thereof a new, different or useful substance or article of tangible personal property is produced for sale or commercial or industrial use . . . “

As you can see, this definition applies to the individual ‘person’, whether they are registered or incorporated as a business or not.  We can find similar manufacturing legislation in every state of the Union.  There is no exemption for individual practitioners, as many would define themselves.

I urge all, whether large corporations, small businesses or individuals to become more aware of the growing legislative efforts across the world that may affect the use of essential oils.  Please join the other 3,593 (and growing) signers in the advocacy efforts to oppose H.R. 5786 and make a point to stay abreast of similar legislative issues.  

Rosewood & Guaiacwood oils Controlled Under CITES Appendix II.

by Tony Burfield. March 2010.

The Environment News Service reported on 19^th March 2010, that two South American trees, over-exploited by essential oil traders for the perfumery & cosmetics market, will be listed under Appendix II, the Convention in International Trade (CITES) in Doha, Quatar has decided. Trade controls (international commercial trading strictly by permit only) will apply within 90 days for Aniba rosaedora (Brazilian rosewood), proposed for listing by Brazil, and for Bulnesia sarmientoi (holywood) from the Gran Chaco region of Central America (from which guaiacwood oil, acetylated guaiacwood oil and guaiyl acetate is produced), proposed for listing by Argentina.

Cropwatch has long drawn attention to the decline in the ecological status of rosewood trees (see rosewood monographs in the Cropwatch Files section of website), and many essential oil users have subsequently volunteered to stop purchasing the essential oil. Unfortunately there is always the unethical element of the trade which will carry on using unsustainable species up until the point at which it is actually illegal to do so Cropwatch has previously named and shamed these concerns, but they seem too set in their ways to take any notice of environmental arguments. The status of holywood (guaiacwood) trees in the Gran Chaco National Park which stretches across W. Paraguay, N. & N.E. Argentina & S.E. Bolivia was recently updated by Cropwatch in its Updated List of Threatened Aromatic Plants Used in the Aroma & Cosmetic Industries v1.19 (see Cropwatch Files). Guaiacwood essential oil is actually a brownish paste melting at 45ºC and acetylated derivatives have occupied an important place in the perfumer’s palette.

But will the listing really make any difference? A CITES Appendix I listing would have been more effective, especially in the case of the rosewood tree, who’s survival is more in the hands of the lawless loggers. Rosewood oil from unlicensed stills deep in the forest continues to find its way into the essential oils market, although some batches show unusual compositions, prompting queries about the species it was sourced from (see Cropwatch’s Rosewood biblio in the Cropwatch Files). Will guaiacwood oil from Paraguay continue to be legally available, or is it just Argentinean origins which will be unavailable? Time will tell, but these CITES listings are, at least, a step in the right direction.

Technorati Tags: Rosewood,aniba rosaedora,bulnesia sarmientoi,holywood,guaiacwood oil,guaiyl acetate

Powerpoint Text: Is excessive regulation destroying the perfumery art?

Presentation linked from previous post converted to a blog post by Rob.

by Tony Burfield Cropwatch  www.cropwatch.org

Safety Issues in the Aroma Business.

• Fragrance customers usually insist on adherence to all existing H&S guidelines (both official & voluntary) because of the prevailing fear-culture, and possible media exposure regarding potential adverse effects to end-users from single ‘hazardous’ fragrance ingredients.
• EU Regulators have no capability of gauging the socio-economic effects of their policies. Banning or restricting natural aromatic materials often has severe economic consequences for natural aromatic producers and dependent communities in developing countries. Disastrous EU legislation is (sometimes) followed by an impact assessment and (then possibly) corrective action – but by then its often too late to save any affected SME’s (e.g. the effect of the BPD on Europe’s natural biocidal product manufacturers).
• Knowledgeable whistle-blowers revealing questionable trade practices are shunned by the trade (for example, as detailed in the letters of the late Stephan Arctander).
• So many SME’s (candle-makers / soap-makers/ incense traders / pot pourri makers / hand-made cosmetics makers / general cleaning product makers / natural perfumers / aromatherapists etc.) cannot afford IFRA / RIFM’s annual fees, & so are locked out of access to a lot of detailed safety data.
• Perfume manufacturing orgs. require the implicit adherence of their members to IFRA Standards & CoP [note: these are not legal requirements, with the exception of Eco-label fragrances]. However many traditional perfumes types, as well as natural, organic & functional perfumes are almost impossible to construct under existing IFRA regulations.
• Safety data is often generated by the major aroma corporates in an atmosphere of secrecy & may have private ownership issues attached; data can be difficult to locate, & expensive or virtually impossible for the general public to obtain. There is also a lack of transparency by regulatory professionals.

Healthy factory environments: at least, nobody ever caught a cold!

 

The ‘Zero Risk Mindset’.

• EU Regulators apply - (or appear to have been pressurised into, by ‘invisible’ lobbyists) a disproportionate & excessive degree of regulation wrt aromatic ingredients, which appears to be an attempt to construct a clean, risk-free and largely synthetic-based world of their own. That is not the world that most of us wish to inhabit, and Cropwatch believes that many will ignore any restrictions which deny us the use of those familiar natural materials which we associate with our lives, our heritage & our traditions.

“..a society that does not try to shape its future ends up being dictated to by its own anxieties.” - Hunt (2004)

So How Dangerous is it to go Outside…?

• The green leaves of trees & plants continuously emit a- & b-pinenes, limonene etc. Shenck (1979) estimated that 438 million tons of monoterpenes* evaporate into the air continually from biological materials [*natural monoterpenes that are designated ‘dangerous for the environment’]. It has been calculated that one European forest puts more chemicals into the environment that the whole EU chemical industry.
• Emitted leaf volatiles also react with ozone to form irritating / sensitising terpene epoxides. Some US fragranced home-care products containing limonene are labelled (paraphrasing): do not use if smog outside !
• Tree leaf volatiles also react with nitrogen oxides from combustion engine emissions causing chemical smogs. Academics at Lancaster University (2002) recommended that UK councils modify the planting of certain VOC emitting trees (maple trees: good; oaks & poplars: bad!) (not, you will notice, take any steps to stop cars emitting nitrogen oxides).

Nature: Presents More Hazards than Using Fragranced Products?

• Inhalation of fern spores poses a cancer risk to countryside visitors / dwellers, & the spores are also a risk to the safety of potable water supplies (Calif. Prop 65).
• Unregulated nuisance farm crops such as mustard seed-rape (flowers & roots) emit allyl isocyanate, benzyl cyanide etc. into the air & soil. Aerial dispersion causes respiratory distress / allergy to many in vicinity (see Rapeseed report: Cropwatch Files).
• This is not to mention the unregulated intake of natural carcinogens, mutagens, toxins etc. consumed in food & spices, & beverages (e.g. methyl eugenol from pesto, safrole from nutmeg, and the CMR1 substance ethanol).

 
Crop of Unregulated Allyl Isocyanate & Benzyl Cyanide Emitters (Brassica napus L. ssp. oleifera) [i.e. Rapeseed or Canola].

Forest of Unregulated a- & b-Pinene Emitters (Pinus sp.), Finland, near Local Aquifer! (can you spot the Daphnia?)

 
Unregulated Phenylacetaldehyde Emitters Lotus corniculatus L. [Birdsfoot Trefoil] growing in the Shetlands! Photo credit: T. Burfield.

 

Unregulated Wild-Flower Coumarin Source (Melilotus officinalis L.) [i.e. Yellow Meliliot from which a perfumery absolute is made].

Unregulated Plateful of Suspected Rodent Carcinogen posing as Foodstuff [A plateful of methyl eugenol containing Pesto!].

REACH.

• Industry is seen as a cash-cow by the EU H&S Commission. REACH registration costs will potentially ruin all but the largest aroma concerns, in spite of concessions for SME’s. The aroma industry magnates therefore divisively support the REACH regulations as a means of eliminating competition.
• The ECHA has created an unmonitored situation under REACH (e.g. for lead registrants & for SIEFS etc.) where bullying and mafia-like activity by large aroma industry corporates has gone unrestricted.
• REACH will severely reduce the available portfolio of fragrance ingredients – Western companies will only be able to make ‘Mickey Mouse’ perfumes.
• REACH has already driven the focus of activity of leading trans-international aroma companies out of Europe.
• Leading toxicologists are opposed to REACH (see next slide)

The Basis of REACH challenged

• The idea that the toxic effects of a chemical show a dose-dependent linear relationship ending at a threshold level is now challenged: at low levels adaptive, non-adverse or even beneficial effects occur (hormesis), and have been shown for >6,000 chemicals (Calabrese 2004).
• This raises a ‘serious misreading of the term toxic’ charge for the EPA, and for the ECHA over the REACH legislation, and suggests that the 50-100 million Euros spent on the exercise is wasted, and will not save a single life.
• The above reference to the EPA needs to be seen as what appears to be a gagging order, mentioned a document prepared by the EPA in 2004, which states that the purpose of a risk assessment is to identify risk (harm, adverse effect etc.), effects that appear to be adaptive, non-adverse or beneficial may not be mentioned. - through Calabrese (2007) ”Belle Newsletter: Introduction. “ Human & Experimental Toxicology 26, 845.

The importance of natural aromatic ingredients.

• Naturals breathe life into an otherwise simple blend of chemicals, adding depth and sophistication - whether floral absolutes, woody materials or citrus oils are employed (many of these ingredients will disappear under REACH).
• Whole fragrance styles / families would not exist without naturals – for example, Eau de Colognes, Eau Fraiches.
• Many landmark fragrances & fragrance styles owe their conception to key natural materials e.g. the chypre style of Mitsouko & Miss Dior, which were based on accords of oakmoss, patchouli oil and labdanum together with bergamot oil.
• Many essential oils lend an incomparable radiant freshness to fragrances e.g. lime, lavender & petitgrain. It is hard to imagine an impressive masculine fine fragrance which merely relies on synthetic materials for its freshness.

A Timid Industry.

• Cosmetic / biocidal / detergent & cleaning ingredient restrictions & regulation proceed with little effective trade questioning or objection in the EU, leading to questions about why industry is so timid (see Durodie 2004).
• But ‘the worm is turning’. In the US, cosmetics-based SME’s are grouping together to prevent financially discriminating legislation acting against them – for example over the crippling fees & costs involved with compliance to the FDA Globalisation Act HR-759, 2009). The Colorado Safe Personal Products Act HB-1248 which proposed zero tolerance for many ‘hazardous’ single cosmetic ingredients (& so was potentially even more extreme than existing European legislation) failed in committee (01.03.2010) due to pressure from SME’s. In S.E. Asia, producers of natural aromatic materials & cosmetics are just starting (Feb 2010) to form anti-regulation groups to protect their livelihoods.

Shortcomings of the EU Cosmetic Commission’s H&S Policies.

• The EU Cosmetics Commissions’ CoP refuses to define ‘safety’, there is no individual ingredient risk quantification, it does not consider ingredient risk / benefit considerations (except for preservatives), it does not allow in-use considerations, & it does not allow for end-consumer adverse reaction statistics to affect safety policy - as apparently this is not ‘bona fide’ evidence (Daskaleros 2007).
• This ‘risk-only’ chemophobic scenario leads to a state of toxicological imperialism, where over-precaution & scare-mongering are de rigueur, and where pharmaceutical & chemical company lobbying disadvantages competitive natural products. Worrying situations of vested interest (e.g. in the SCC(S)(P)) remain unaddressed. Europe has become a hostile environment for perfumery; many concerns have relocated outside the EU.

A Lack of Cross-Disciplinary Expertise..

• EU Cosmetic Comm. staff admitted to Cropwatch (Brussels 2007) they were unable to find the services of a botanical expert, and the SCCP had no literature search ability until 2007 (& so previously could not properly independently review the evidence presented to them). Now a pool of 160 ’experts’ is supposedly to be made available to Brussels staff (but no word on any botanists!).
• The previous safety assessments of many / most natural fragrance ingredients by RIFM have proceeded via industrially donated materials which have not been botanically identified at source by an expert, were not batch-tracked and not proven as 100% derived from the named botanical. The lack of forensic and taxonomic application has led Cropwatch to describe a number of IFRA Standards as non-robust, where botanical identifications (as published) are either incorrect, incomplete or based on false assumptions of ingredient purity e.g. for opoponax (see Cropwatch Files - Opoponax).

..and a Lack of Ecological Awareness..

• The industrial over-exploitation of many natural aromatic species by the Cosmetics & Pharmaceutical industries remains virtually unchecked – by the time a CITES listing or an IUCN Red Listing is in place, it is often too late to save the species under threat, or the full compliment of its’ genetic diversity.
• For example while IFRA pondered a new Standard for styrax qualities, less than 15 hectares of Asian styrax trees remained unlogged in Turkey.
• Commodities from rare or threatened species include: agarwood oil, sandalwood oil East Indian, sandalwood oil East African, rosewood oil, Cedrela odorata oil, guaiacwood oil, copaiba balsam, gurjun balsam, candeia plant spp., costus qualities, Parmelia (fragrant lichen) qualities, some frankincense yielding spp. e.g. Boswellia papyrifera, chaulmoogra oil and many others (see Cropwatch data-base on Threatened Aromatic Species).

Media Bad Science on Naturals – an Example.

• Gynecomastia in 3 pre-pubertal boys, allegedly caused by using lavender/TTO-containing cosmetics / personal care products (Henley et al. 2007), received much newspaper coverage in 2007-8. The New England Journal of Medicine which ran the article, had previously announced a policy change, as it could not find independent experts for peer reviewing, who had not been paid off in some way by industry (Newman 2002). A pity, since refutation of the robustness of science behind the alleged gynecomastia-lavender/TTO link followed [e.g. by Nielson (2008) & Lawrence (2007) amongst others], but of course, received no attention from the popular media.

Bad Science on Naturals in Peer-Reviewed Journals – An Example.

According to Frosch, White et al. (2002):

• patchouli oil contains cinnamic aldehyde, benzaldehyde & eugenol!
• Atlas cedarwood oil contains alpha-ionone!
• sandalwood oil contains geraniol & citronellol!
• the main components of spearmint oil are limonene, 3-octanol, menthone and dihydrocarvone (but no mention of the major constituent: carvone!)

Ref: Frosch P.J., Johansen J.D., Menné T., Pirker C., Rastogi S.C., Andersen K.E., Bruze M., Goosens A., Lepitoittevin J.P. & White I.R. (2002) “Further important sensitisers in patients sensitive to fragrances II - Reactivity to essential oils.” Contact Dermatitis 47, 279-287.

Destroying the very foundations of perfumery.

• The restriction/banning of key fragrance ingredients on dubious / over-precautionary safety grounds, can easily compromise the founding elements of the traditional perfumery art. For instance, the crucially important fougère perfumery accord consists of a combination of bergamot, coumarin & oakmoss.
• Bergamot oil usage is under threat from potential EU legislation because of its allegedly photo-toxic furocoumarin (FC) content (see flawed SCCP Opinion 0942/05, then compare with the Cropwatch FC data-base).
• Oakmoss was originally proposed to be restricted as a sensitiser under SCCP/1131/07, limiting the potent sensitisers atranol & chloroatranol to 2ppm in product. Cropwatch (2009) described this Opinion as unsafe from a failure to consider all the published evidence (which it has subsequently made publicly available). EU policy on oakmoss / treemoss has since been modified.

Public Objections to ‘Safe’ Reformulations of Classic Perfumes.

• Reformulations of classic perfumes, carried out in order to conform to modern regulatory requirements, have led to disappointment and bitterness amongst their long-term devotees, whose historical memories and emotional attachments are evoked by the odour profiles of particular fragrances, as part of their rightful cultural inheritance. Many fragrance houses seem in-denial about the whole subject, but Turin (2007) has remarked on customer anger generated during the Guerlain Mitsouko reformulation debacle. Internet discussions on a wider range of classic perfumes whose character has been allegedly mutilated by reformulation are available (for example see Perfume of Life Forum Jan 2007)…

Natural Ingredient Usage Declines.

• The usage of naturals has declined in perfumery from downward pressure on ingredient costs (synthetics are comparatively cheaper), erratic supply (climatic & geophysical events; political events; demand pressures) & from stability & compositional issues.
• Under existing EU H&S policy, natural complex substances are treated as a collection of individual composite chemicals. The vast majority of essential oils, absolutes & resinoids contain several of the 26 named allergens, which have to be labelled under EU Directive 2003/15/EC (now under review). The desire by cosmetic manufacturers to avoid excessive product labelling has previously lead to some decline in the overall usage of essential oils.
• Under CHIP / EU DPD & DSD (now under the CLP 1272/2008/EC), R50/53 environmental labelling (dead fish / dead tree symbols) and R65 labelling have had a serious impact on usage of citrus oils & their terpenes. Citrus oils have been traditionally employed in many types of perfumes for household & air care products due to their diffusion, lift & fresh character, but perfumers now find it difficult to use them for the reasons above. Ditto for pine needle oils.
• Cinnamon leaf & clove oils were used in pot pourris & candles, but R43 issues with cinnamic aldehyde & eugenol contents etc. mean that their use is restricted.
• Minor oils that IFRA has banned / restricted on predictive toxicological grounds, but has no funds to practically investigate – melissa, santolina, boldo etc. NB Cropwatch recently published the Robertet toxicological evidence on melissa oil showing the original IFRA ban was unjustified
• Natural products needing expert botanical identification & chemical analysis for QRA studies, are/were not supported (read: can’t afford to support) by IFRA– opoponax, styrax..

The ‘Weak Animal Carcinogens’ Issue.

• The EU classification of methyl eugenol as a suspected rodent carcinogen & mutagen, and safrole as a hepatocarcinogen, together with corresponding IFRA restrictions, has led to a great reduction in the use of those natural materials which contain them, such as the methyl eugenol-containing spice oils: clove bud, pimento leaf & pimento berry. The use of rose oil has been similarly affected - it is now virtually impossible to create a 100% natural rose fragrance which complies to IFRA guidelines, formulated with >1% rose oil. Use of cinnamon leaf & nutmeg oils too, has also been curtailed by the safrole classification, as has the use of basil & tarragon oils containing estragole (weak carcinogen, weak mutagen).
• Such limitations have had significant effects on fragrance styles entering the market place: traditional aromatic masculine fougères and rich spicy notes are very difficult to achieve at so-called ‘safe’ levels.

Some Inconvenient Classifications.

• Safrole: carcinogen cat. 3 mutagen cat. 2 (EFFA CoP 2009). Occurs in sassafras, nutmeg, mace, star anise & cinnamon leaf oils.
• Methyl chavicol: Possible weak genotoxic hepatocarcinogen (SCF 2001). Occurs in star anise, exotic basil, fennel, tarragon oils.
• Methyl eugenol: Possible carcinogen (US). Calif. Prop. 65 carcinogen. Occurs in rose, basil, bay WI, cananga, citronella Sri Lanka, pimento, lovage & betel oils etc. Human exposure levels normally several magnitudes below bioassay levels for rats, mice; relevance of rodent data questioned (Robison & Barr 2006).
• Ethanol: CMR cat 1. Cosmetic manufacturers are currently withdrawing ethanol from mouthwash formulations. Indispensable ingredient to cosmetics trade.

Legislation-Compliant Ingredients?

• Cropwatch has a large A-Z data-base of articles on the various furocoumarin (FC) contents of natural products following FC phototoxicity issues (under SCCP/0942/05 etc.). Companies like Treatt, Capua etc. now market a range of FC-free citrus oils, but small traditional producers of citrus oils are potentially disadvantaged without huge technology investments. And for what reason? The safety case for reducing FC’ s to the minute levels the EU proposed in cosmetic products is not robust, and other commonly used cosmetic ingredients also show photo-toxic effects.
• To date, safrole-free nutmeg qualities, methyl eugenol-free rose oil, IFRA compliant oakmoss qualities, furanocoumarin-free bergamot oil etc. etc. have all proven to be more-easy-to-adulterate, pale olfactory shadows of traditionally produced natural products. This reduction in ingredient quality compromises the art of the possible in perfumery practice.

‘Allergic’ Fragrance Ingredients.

• SCCNFP in Opinion SCCNFP/0017/98 & 0329/00 identified a number of fragrance chemicals (16 of which occur in natural products) associated with a labelling obligation for allergens where conc. in the final product is <0.01% in products rinsed off the skin products or <0.001% in leave-on products. This was incorporated into Council Directive 2003/15/EC. The basis for the inclusion of these chemicals as allergens has never been explained by the SCCP (Storrs 2007). The chairman of the SCCP (Ian White) has co-authored a number of research papers on alleged allergens, & cannot be said to be a disinterested party.
• Independent papers / peer-reviews (e.g. those by Schnuch, Flocfh, Vocanson, several by Hostynek & Maibach) have indicated that there is no robust clinical or experimental evidence to support many of these 26 ingredients as allergens. Schnuch (2008) asked the EU to rethink their policy.
• Hostynek & Maibachfs (2008) detailed article on gAllergic Contact Dermatitis to Linalool: Allergen Status Disqualifiedh has appeared in a third consecutive journal/trade magazine.
• A request for an updated scientific opinion on the labelling of 26 fragrance substances which were introduced into Annex III of the Cosmetics Directive by 2003/15/EC was made by the EU Commission of the SCCP, politically passed off as ‘a spin-off from the public consultation (Nov 2006) on the Commission proposal of regulation of some fragrance substances’.
• "Scientific information of general and specific nature has been submitted to DG-ENTR. in order to ask the SCCP for a revision of the 26 fragrances with respect to further restrictions and possible even delisting.”
• “At that time there were not sufficient scientific data to allow for determination of dose response relationships and/or thresholds for these allergens”.

- Cropwatch comments: if this is manifestly correct, why did they go ahead with the legislation?

• The older Opinion SCCNFP/0017/98, divided allergens as most frequently listed (list A) and infrequently listed (list B), but the recent Brussels request to the SCCP (see previous slide) makes no reference to the work of Schnuch et al. (2007), who called for a slightly different list of substances to be reviewed as allergens, on the basis of his published work indicating there were no safety concerns to consumers for a number of these SCCP allergens.

The Tea Tree Oil (TTO) Debacle

• TTO is in a Catch-22 situation. It is universally acknowledged by microbiologists as a useful biocide except by the EU Biocides Commission. Therefore, apparently, TTO in EU cosmetic products ‘does not have a cosmetic purpose’ (SCCP/1155/08).
• Also according to SCCP/1155/08, diluted TTO might be unstable in cosmetic formulations, skin & eye irritation not assessed by adequate methods. The SCCP identified data-gaps relating to subchronic toxicity, percutaneous absorption, genotoxicity / carcinogenicity & reproductive toxicity.
• The ATTIA (& RIRDC) made the big mistake of submitting a safety dossier to the SCCP on these shortcomings, at a cost of £200,000 Australian, thus creating a precedent for the whole essential oils industry. The SCCP took nearly 2 years to evaluate their data, and still were not satisfied.
• Adverse end-user reactions from sales of tens of millions of small bottles of TTO by major distributors runs at < 0.0015% (Cropwatch, unpublished data).

Vanillin

• Under IFRA’s 44th Amendment, vanillin was at first restricted on alleged QRA sensitisation grounds, but this restriction is currently suspended (this dithering costing industry hundreds of thousands of Euros in reformulation, ingredient stock adjustment, costs of buying in substitution stock and re-labelling). Current vanillin consumption is about 6,000t/y.
• Vanillin has been the foundation of the oriental fragrance family formed from accords of vanillin, balsams, spices, patchouli, woods, salicylates and citrus oils. Jicky, created in 1889 by Guerlain was the first major oriental fragrance founded on this accord.
• In the early to mid 1990s a major vanillic trend was founded on an overdose of vanillin and vanilla. Beginning with Vanilla Fields (Coty 1993), a host of sweet vanillic floral and vanillic floriental fragrances were launched e.g. Tocade (Rochas 1994), Loulou Blue (Cacherel 1995), Le Male (J. P. Gautier 1995), Allure (Chanel 1996), Ghost (2000). This trend of the 1990s has lead to a general sweetening of fragrance styles, (and consequently a generally higher use of vanillin), which is apparent today in the myriad of oriental masculine styles (e.g. 212 Sexy for Men 2006) and fruity floral feminine types and fruity florientals (e.g. Delicious Night DKNY 2007).
• Evidence for the alleged very weak sensitising activity of vanillin (according to IFRA) rests on 3 pieces of evidence, 2 of which are hardly new but are unavailable to the general public:

Basketter D.A., Wright Z.M., Warbrick E.V., Dearman R.J., Kimber I., Ryan C.A., Gerberick, G.F., White I.R. (2001). “Human potency predictions for aldehydes using the local lymph node assay.” Contact Dermatitis, 45, 89-94.

RIFM (Research Institute for Fragrance Materials, Inc.), 1970. Maximization study with vanillin. RIFM report number 1760, October 7. (RIFM, Woodcliff Lake, NJ, USA).

RIFM (Research Institute for Fragrance Materials, Inc.), 2009. Human repeated insult patch test. DRAFT REPORT. (RIFM, Woodcliff Lake, NJ, USA).

• Opposing evidence to the sensitising potential of vanillin was listed in Cropwatch Newsletter 15 – for example >99% vanillin ex lignin has been found non-sensitising. But it is likely that this major fragrance ingredient will yet suffer severe usage restrictions on dubious QRA testing grounds.

Coumarin

• Coumarin is regulated by EU Directive 2003/15/EC such that coumarin requires labelling as a sensitiser if present at concentrations of >10ppm in fragranced leave- on products, or >100 ppm in fragranced products washed off the skin.
• SCCP Opinion /0935/05 on 99.9% pure coumarin, shows the expert committee had misunderstood the data, incorrectly concluding that pure coumarin is a sensitiser - Schnuch (2004), Floc’h et al (2002), Vocanson et al (2006 & 2007) and many others have opposing views. Cropwatch’s submission to DG-Ent. on coumarin was never acknowledged.
• Minor impurities in some commercial grades of synthetic coumarin used for allergy testing (dihydrocoumarin; 6-chlorocoumarin etc.) may however be sensitising.

Only 1 well-documented clinically relevant case of allergy to coumarin has ever been reported (Mutterer et al. 1999). Low numbers of clinically relevant cases exist for many other alleged allergens listed under EU Directive 2003/15/EC. The legislation clearly lacks proportionality.

• EFSA (2004) concluded that coumarin is non-genotoxic. Any human carcinogenicity issues may only be relevant to very small sub-section of human population (Lake 1999).
• Federal Institute for Risk Assessment (BfR) had to be publicly corrected in 2007 on alleged risks with coumarin toxicity from cosmetics. The BfR had wrongly maintained that the TDI (0.1mg/d) for coumarin could be exceeded by the normal application of cosmetics. Commentators are on record as saying that Prof. Hensel has, additionally, not understood species differences relevant to coumarin metabolism.

Other Fragrance Ingredients with Questionable Restrictions.

• Benzaldehyde (used for almond & cherry notes); tagetes oils & absolutes; oakmoss & treemoss qualities; FC-containing citrus oils; opoponax & styrax qualities; jasmine absolute; santolina, boldo & melissa oils; oils of the Pinaceae.
• All of these and many others have been discussed by Cropwatch (see website), and many are the subject on on-going investigations to reverse the hasty & over-precautionary limitations imposed.

References.

• Calabrese E.J. (2004) “Hormesis – basic, generalisable, central to toxicology and a method to improve the risk assessment process” J Occup Enviro Health 10(4), 466-7.
• Calabrese E.J. (2007) ”Belle Newsletter: Introduction. “ Human & Experimental Toxicology 26, 845.
• Daskaleros T. (2007) remarks made during Cropwatch meeting with EU Cosmetics Commissioners & DG-Ent staff 2007 Brussels, July 2007.
• Durodie B. (2004) “The timid corporation – why business is terrified of taking risk.” Risk Analysis 24(1), 2004.
• EFSA (2004)
• Floc’h F. (2002) “Coumarin in plants and fruits: implications in perfumery.” Perf. & Flav. 27 (Mar/Apr 2002), 32-36.
• Frosch P.J., Johansen J.D., Menné T., Pirker C., Rastogi S.C., Andersen K.E., Bruze M., Goosens A., Lepitoittevin J.P. & White I.R. (2002) “Further important sensitisers in patients sensitive to fragrances II - Reactivity to essential oils.” Contact Dermatitis 47, 279-287.
• Henley D.V., Lipson N., Korach K.S., Bloch C.A. (2007) “Prepubertal gynecomastia linked to lavender and tea tree oils.” New England Journal of Medicine 356 (5), 479–485.
• Hostynek J. & Maibach H. (2008) “Allergic contact dermatitis to linalool” Perfumer & Flavourist 33, 52-56.
• Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that anisyl alcohol causes allergic dermatitis?" Exog. Dermatol. 2, 230-33.
• Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that amylcinnamic aldehyde causes allergic dermatitis?" Exog. Dermatol. 3, 35-46.
• Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that linalool causes allergic dermatitis?" Exog. Dermatol. 2, 223-229.
• Hostynek J.J., Maibach H.I. (2004) “Is there evidence that geraniol causes allergic contact dermatitis?” Exog. Dermatol. 3(6), 318-331.
• Hostynek J.J., Maibach H.I. (2004) “Sensitisaton potential of citronellol” Exog Dermatol 3(6), 307-312.
• Hostynek J.J., Maibach H.I. (2004) “Is there evidence that alpha-methyl-ionone causes allergic contact dermatitis?” Exog. Dermatol. 3(3), 121-143.
• Hostynek J.J., Maibach H.I. (2006) “Is there evidence that alpha-methyl-ionone causes allergic contact dermatitis?” Cutaneous & Ocular Toxicol. 25(4), 259-271
• Hunt B. (2004) The Timid Corporation – Why Business is Terrified of Taking Risk
• Lake B.G. (1999) “"Coumarin metabolism, toxicity & carcinogenicity: relevance for human risk assessment" Food and Chemical Toxicology 37, 423-453
• Lawrence B.M. (2007) “Estrogenic activity of lavender & tea tree oils Part II.” Perf. & Flav June 2007.
• Mutterer V., Giménez Arnau E., Lepoittevin J.P., Johansen J.D., Frosch P.J., Menné T., Andersen K.E., Bruze M., Rastogi S.C., White I.R. (1999) "Identification of coumarin as the sensitizer in a patient sensitive to her own perfume but negative to the fragrance mix." Contact Dermatitis. 40(4):196-9.
• Nielsen J.B. (2008) “What you see may not always be what you get – Bioavailability and extrapolation from in vitro tests.” Toxicology in Vitro
• Newman N. (2002) "Big Pharma, bad science." The Nation 25 July 2002.
• Robison S.H. & Barr D.B. “Use of biomonitoring data to evaluate methyl eugenol exposure.” Environ Health Perspect. 114(11), 1797-18001.
• Schnuch A. (2004) Öko-Test, No. 7 (July) 2004, 55
• Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) “Sensitization to 26 fragrances to be labelled according to current European regulation. Results of the IVDK and review of the literature.” Contact Dermatitis. 57(1),1-10.
• Shenck G.O. (1979) Perf Kosm 60, 397.
• Storrs F.J. (2007) “Allergen of the year: fragrance.” Dermatitis 18(1),3-7
• Turin L. (2007) “Due Credit” NZZ Folio 04/07.
• Vocanson M. (2006). "The skin allergenic properties of chemicals may depend on contaminants – Evidence from studies on coumarin." Int Arch Allergy Immunol 140, 231–238
• Vocanson M. et al. (2007) “Lack of evidence for allergenic properties of coumarin in a fragrance allergy mouse model.” Contact Dermatitis 57(6), 361-364.

Acronyms.

• ATTIA – Australian Tea Tree Industries Association
• BfR - Federal Institute for Risk Assessment
• BPD – Biocidal Products Directive
• DG-ENT - Directorate General (Branch of European Commission responsible for Industry)
• CoP – Code of Practice
• E.O. – Essential Oil
• ECHA - European Flavour & Fragrance Association
• EFSA - European Flavour & Fragrance Association
• FC – FuroCoumarin
• H&S – Health & Safety
• IFRA - International Fragrance Association
• QRA - Quantitative Risk Assessment
• REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals
• RIFM - Research Institute for Fragrance Materials
• RIRDC – Rural Industries Research & Development Corporation (Australian Govt).
• SCCNFP - Scientific Committee on Cosmetic Products and Non-Food Products
• SCCP - Scientific Committee on Consumer Products
• SCF – Scientific Committee on Food
• SME – Small to Medium sized Enterprise
• TDI - Tolerable Daily Intake
• TTO – Tea Tree Oil
• VOC – volatile organic carbons

Editors Note: This was converted from a Power Point document by Rob. The formatting of the references is incomplete, and I did not add links to many previous posts on this blog which deal with many of the materials discussed herein. Those may come later, as will the reference formatting.

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