May 14, 2013

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,, and others, with an index to all the articles hosted on a now dead site: (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 which takes you to an introductory page.  The actual Index page is

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.

Posted by Rob on May 14, 2013 in Aromatherapy, Essential Oils/Plant Extractions, Oil Crops, Safety/Toxicity, Weblogs | Permalink | Comments (0) | TrackBack

August 29, 2012

Book review: The Chemistry of Essential Oils Made Simple

By Robert Tisserand

At almost 850 pages, there’s plenty of reading here. Unfortunately, this book is replete with errors. There are innumerable mis-spellings of the names of chemicals. Terpinen-4-ol is an alcohol, not a phenol, and bergamotene is a terpene, not a furanocoumarin. On page 374 we read that “Coumarins are thought to be antispasmodic, as are many other esters.” Coumarin is not an ester. Stewart mentions that myrrh oil is rich in ‘furanoid compounds’ – well yes, it is indeed rich in FURANS, and he goes on to say that“furanoid compounds can amplify ultraviolet light and can make an oil phototoxic.” (p23/24). Well, I don’t know why he wants myrrh oil to be phototoxic, but it isn’t, because it contains no FURANOCOUMARINS. Using the term ‘furanoid compounds’ fails to make a vital distinction – between (phototoxic) furanocoumarins, and (non-phototoxic) furans.

In some cases Stewart seems to have copied mistakes from other sources, without realizing they were mistakes. l-Limonene is quite often given instead of d-limonene, and methyleugenol has curiously disappeared as an essential oil constituent altogether – Stewart does not list it a constituent of any of the oils it is actually found in! Furanocoumarins are frequently cited that may indeed be present in the plant but are not found in the essential oil.

He has made a valiant effort to list the components of 113 essential oils, but the method he used – combining data from various books – is risky. The end result is said to represent a ‘typical’ essential oil, but is rather hit-and-miss, and in many cases does not represent any existing essential oil at all. Some of the total percentages add up to more than 100%. Reporting constituent chemistry from different sources is a challenge I am often confronted with myself, but there are more elegant solutions.

Stewart is highly critical of what he calls the ‘British School’ of aromatherapy, because it espouses the idea that some essential oils can be dangerous, and because, according to Stewart, it “relies on scientific research on animals”. However, he does take on board the idea that some furanocoumarins are phototoxic. Stewart perhaps does not realize that phototoxicity in essential oils is almost entirely based on RIFM research using pigs, and much of the ‘French’ information about essential oil constituents that Stewart cites is based on animal research. If the book was properly referenced, this would be obvious. He also criticizes the British for “usually applying only certain compounds isolated from essential oils rather than the whole oil.” (p4) It is difficult to fathom from where he plucked this outrageous notion!

There is a massive amount of information here, but there is not a single scientific reference to back up any of it. The result is an uncomfortable mix of fact and fiction. The book perpetuates the myth that any dangers of essential oils (apart from phototoxicity) only apply to what he calls ‘perfume grade’ oils, which, according to Stewart, British aromatherapists like to use! I’m not sure then, who buys all the independently certified organic essential oils sold in Britain. There is no ‘perfume grade’ of essential oil (on either side of the Atlantic), nor is there a ‘therapeutic grade‘. [The grades that do exist are various organic certifications, ISO standards, BP (British Pharmacopeia) standards, and FCC (Food Chemicals Codex) standards.]

Stewart does humanity and science a disservice by alleging that it is impossible for an essential oil to cause an allergic reaction: “Occasionally, a person receiving essential oils claims to have had allergic reaction to them….such a reaction is never allergenic…they are usually therapeutic and indicate the initiation of a cleansing, healing process.” (p451) Stewart goes on to explain his hypothesis that essential oil constituents cannot be allergenic, because they are not composed of amino acids. No, they are not composed of amino acids, but yes, they can in fact cause allergic reactions, because an essential oil constituent such as cinnamaldehyde (known as a ‘hapten‘) can combine with proteins in the skin and can then be recognized by the immune system as an allergen. This is not new science, and Stewart’s bending of the facts to suit his world view is shameful and potentially dangerous.

There is a lot of information in this book and it is by no means all wrong, but the fact-to-error ratio is too rich for me, and the way he plays with words to make ‘his truth’ look like fact is disturbing. On page 462 he states: “There has never been a documented instance of antigen-antibody response (i.e. sensitization) to an essential oil. Essential oil antibodies have never been found or detected in anyone. Never.” The last part is true, but only because (a) you can’t have an antibody to an essential oil, only an essential oil constituent (is this genuine ignorance of basic biology, or just more fact-bending?), and (b) no scientist has ever found antibodies to essential oil constituents, because no scientist has ever looked for them. Perhaps the clinical reality of an allergic reaction needs no proof. Here are two documented cases of allergic reaction to cinnamon bark oil:

Ackermann L, Aalto-Korte K, Jolanki R et al 2009 Occupational allergic contact dermatitis from cinnamon including one case from airborne exposure. Contact Dermatitis 60:96-99

Sánchez-Pérez J, García-Díez A 1999 Occupational allergic contact dermatitis from eugenol, oil of cinnamon and oil of cloves in a physiotherapist. Contact Dermatitis 41:346-347

The IFRA safety standards require that cinnamon bark oil should not be used on the skin at more than 0.6%, to avoid allergic reactions.
Essential Oil Safety – a rebuttal
Stewart is critical of my book, Essential Oil Safety. Here are some of his comments:
Much of the research cited is on the toxic effects of single components of an oil, which is an invalid application of science. This is an incredible statement, considering that most of Stewart’s book is devoted to explaining essential oil chemistry, and the relationships between constituents and therapeutic properties. On page 468, for instance, Stewart says: “essential oils rich in phenols should be used with caution when applying to the skin.” If extrapolating single component data to whole essential oils is not OK when I do it, why is it OK when Stewart does it?

Furthermore, as the authors point out, in all of the studies they cite, the data are for animals (not people) and/or the tests were not for the whole oil but for isolated compounds of an oil. These types of studies are not valid indicators of the behavior of oils in actual practice. (p21/22) This is simply not true, and is not stated anywhere in the Essential Oil Safety text. There are many studies cited in Essential Oil Safetywhere whole essential oils were patch-tested on individuals (such as the two reports for cinnamon above), and there are many cited cases of poisoning from whole essential oils. And, see my previous comment.

There are two places where I have been mis-quoted:

1) In the preface the authors state “this text was largely an extrapolation of toxicological reports from the Research Institute for Fragrance Materials (RIFM).” In other words, this book is based on data that apply only to perfume grade oils which are customarily refined, denatured, and laced with synthetics. (p787)

This is what the preface actually says:
“This book [i.e. Essential Oil Safety] replaces The Essential Oil Safety Data Manual by Robert Tisserand, first published in 1985. This text was largely an extrapolation of toxicological reports from the Research Institute for Fragrance Materials (RIFM).” So , I was not referring to Essential Oil Safety at all, I was referring to a previous, and very much smaller book.

2) These authors state on p ix, “the majority of essential oils we recommend should not be available to the general public”. In their opinion, the majority of essential oils should be restricted only to what they would regard as “qualified aromatherapists.” (p788)

This is what is actually said:
“In the UK and USA at least, it is currently possible to purchase, by mail order, the majority of the essential oils which we recommend should not be available to the general public.” Stewart is trying to make it sound as if I don’t believe essential oils should be available to the general public. Of the 450 odd essential oils produced today, I do believe that a dozen or so should not be publicly sold, because they are so toxic. To suggest that I am not in favor of ordinary people having access to essential oils is just incredible. David Stewart, what do you think I have been doing for the past 40 years? Why is there a brand of essential oils called Tisserand Aromatherapy? Why are these essential oils available to anyone? Why did I write The Art of Aromatherapy in 1977? And what was I thinking when I wrote a book called Aromatherapy for Everyonein 1988?

In both cases, by omitting the first part of the sentence, the meaning has been completely changed. And in the second quote, two words were omitted to further change the meaning. It’s sad that someone should invest so much energy in writing a comprehensive text, and then sabotage it by trying to bend the truth to suit a commercial agenda. (And if there is no commercial agenda, why are Young Living products mentioned throughout the book?)

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

Posted by Blogmistress on August 29, 2012 in Aromatherapy, Education, Research, Safety/Toxicity | Permalink | Comments (0) | TrackBack

April 04, 2012

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.

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.

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.

Posted by Blogmistress on April 4, 2012 in Aromatherapy, Essential Oils/Plant Extractions, Perfumery, Safety/Toxicity, Standards | Permalink | Comments (4) | TrackBack

March 22, 2012

GM (Genetically Modified) Eucalyptus is one step closer

This is not a new story, but merely another step in the historical process of moving agriculture towards the use of GM in aromatic plants (Although this Eucalyptus is being developed for timber and not for making essential oil.)

The Institute of Science in Society reports on their website on the latest news  in the saga of GM Eucalyptus approval for field testing. In an article ‘Confined’ field releases of Eucalyptus neither confined nor safe scientists at ISIS have criticized the Environmental Analysis process on grounds “uninformed prejudice and hiding crucial details”. The two Eucalyptus species (E. Grandis) and (E. urophylla) that have been hybridized and then cloned are not generally considered to be of aromatic use, but are used for timber. An American Corporation ArborGen has applied for permission to release the clone into the environment in the southeastern US to test how well their genetic modifications work. ISIS does not believe that the Environmental Assessment has adequately addressed a number of important issues. They have asked for wide circulation of their information and granted blanket permission for reproduction, so the aromaconnection is reposting the entire post here so that our readers can see for themselves some of the issues that will arise if genetically modified plants are used. A major part of the concern is the lack of transparency as well as potential safety issues.

ISIS Report 21/03/12

‘Confined’ field releases of Eucalyptus neither confined nor safe

Perfunctory environmental assessment based largely on uninformed prejudice and hiding crucial details on gene constructs under ‘Confidential Business Information’ Prof. Joe Cummins and Dr. Mae-Wan Ho

Please circulate widely and repost, but you must give the URL of the original and preserve all the links back to articles on our website

‘Confidential Business Information’ makes a mockery of risk assessment

An application from ArborGen has taken a sinister turn in declaring most, if not all of the genetically modified (GM) constructs in a Eucalyptus hybrid clone to be tested in environmental release ‘Confidential Business information’, thereby precluding any meaningful independent safety and environmental assessment of the GM trees, or appropriate remedial action and identification in case of harm caused to the environment and innocent bystanders.  The USDA/ APHIS (United States Department of Agriculture/Animal and Plant Health Inspection Service) has yet again made a highly flawed Environmental Assessment (EA) on the proposed release, dismissing every issue on safety largely on a priori assumptions and in the absence of real data [1].

ArborGen, LLC, based in Summerville, South Carolina, has applied for the ‘confined’ environmental release of the clone EH1 of a Eucalyptus grandis × Eucalyptus urophylla hybrid genetically modified with various constructs at six locations encompassing a total of 14.7 acres in the States of Alabama, Florida, Mississippi, and South Carolina [2]. (As of September 2011, ArborGen is growing a total of approximately 67 acres of GM trees on 18 of the 32 permitted locations.) Five of the locations for the current release already have active APHIS permits for GM trees granted previously. The sixth site in South Carolina has been listed as a holding site for GM trees in previous APHIS permits and notifications, and is a new location for the release of GM Eucalyptus. ArborGen is requesting that trees be allowed to flower at four locations in Alabama, Florida and Mississippi. At two locations in South Carolina, ArborGen has requested to release trees in containers and have indicated they will not allow the trees to flower.

The stated purpose of the field release is to assess the effectiveness of different gene constructs intended to confer cold tolerance, to alter lignin biosynthesis, to alter growth rate, along with testing the efficacy of the barnase gene designed to alter fertility. In addition, the trees have been engineered with a selectable marker that confers resistance to the antibiotic kanamycin. With the exception of the C-Repeat Binding Factor (CBF) gene (see later), the barnase gene, and nptII gene, all genes are claimed as Confidential Business Information (CBI), even though they are different constructs from those in trees previously permitted for environmental releases by APHIS.

The designation of the majority of transgenic modifications CBI certainly prevents any rational, independent evaluation of the impact of those genes and the GM Eucalyptus on the environment, and on human and animal health.  Unfortunately, USDA does not appear to have a mechanism for identifying and discarding frivolous CBI designations.  The avalanche of CBI designations of transgenic crop and tree modifications suggests that the designation is being used to avoid doing proper risk assessment and also making it impossible for independent risk assessments that could otherwise be done; and in addition, prevent the detection of adverse side effects due to the modifications, which would also make it impossible to take appropriate remedial action. This is clearly unacceptable for protection of public health and the environment. The USDA should open the CBI designations to independent adjudication.

A number of risks were assessed in a perfunctory fashion and dismissed based to varying degrees on a priori assumptions in the absence of real data from dedicated investigations.

Alteration in susceptibility to diseases or insects

This was dismissed largely on basis of the statement in ArborGen’s application that “none of the genes being engineered into the Eucalyptus plants are expected to alter the susceptibility of the transgenic Eucalyptus plants to disease of insect damage.”

We have previously pointed out that reducing lignin in trees would make them more susceptible to attack by insects and pathogens (see [3] Low Lignin GM Trees and Forage Crops, SiS 23).

Risks from transgenes

Kanamycin resistance Risks from the kanamycin resistance gene is dismissed even though we have pointed out that kanamycin is still in clinical use and also kanamycin resistance cross-reacts with new antibiotics  [4] (Kanamycin Still Used and Cross-Reacts with New Antibiotics, ISIS Report).

Cold tolerance C-Repeat Binding Factor (CBF) genes are transcription factors belonging to the AP2/EREBP family of DNA binding proteins, which recognize a cold- and drought-responsive DNA regulatory sequence designated the C-repeat (CRT)/dehydration-responsive element (DRE), found in the promoter regions of many cold-inducible genes. When CBF genes are overpressed constitutively, as when placed under the control of the CaMV 35S promoter, it was associated with stunting, reduced flowering and lack of tuber production in potatoes. However, when the CBF gene was placed under the control of a cold-induced promoter, rd29A, it increased tolerance to freezing while restoring growth and tuber production to wild-type levels. The GM Eucalyptus trees tested have the CBF gene under the control of a cold inducible promoter, which causes the gene to be expressed only when cold, and hence “not expected to produce any toxic substance and is not expected to alter the characteristics of the engineered plants”.

This large assumption is far from justified as the Eucalyptus version, EguCBF1, when over expressed, not only results in cold tolerance,  but also increased water retention, higher oil gland  density and wax deposition, and over expression of anthocyanin  pigments [5].  The gene network influenced by CBF gene modification produces highly pleiotropic effects. But there does not appear to have been any investigation on the production of unintended metabolites, proteins, or nuclei acids in the  modified trees, all of which could have health and environmental impacts.

Gene for altered fertility We have commented on the dangers of the barnase gene on numerous previous occasions, most recently in 2008 [6] USDA FONSI for Transgenic Poplars Absurd & Dangerous, SiS 38). It is a well-known cytotoxic protein that breaks down RNA. Because they are from a soil bacterium, and unrelated to any mammalian RNAses, they are not susceptible to eukaryotic RNAse inhibitors. Consequently, they are highly toxic, and are actually being engineered currently as a means of killing cancer cells [7]. But USDA has dismissed the dangers of this gene in the current EA as in previous EAs. This is unconscionable. Although the barnase is being used to prevent pollen formation, this is not 100 effective, and many beneficial insects and other wild-life could well be affected.

Apart from the above genes, the genes for altered lignin (3 of them), genes for altered growth (4), non-coding sequences (undisclosed number derived from plants and plant pathogens), were all not mentioned or explicitly not disclosed under CBI, and consequently, not risk assessed at all before stating that they are not expected to pose any risks.

Mode of transformation and hazards of horizontal gene transfer

One aspect that needs to be highlighted is the mode of transformation of the GM Eucalyptus involved Agrobacterium. This is a serious unresolved hazard in genetic modification that we have drawn attention to for years, most recently in 2011 [8] Scientists Discover New Route forGM-gene 'Escape' (SiS 50). Research commissioned by the UK Department of the Environment, Food and Rural Affairs (DEFRA) in the 1990s had already revealed that it is very difficult, if not impossible to get rid of the Agrobacterium vector used in creating the transgenic plant. The bacterium is likely to remain dormant even after the transgenic plants are transplanted into the soil. Hence, it is expected to facilitate horizontal gene transfer, in the first instance, to wild-type Agrobacterium in the soil, and further afield, to other bacteria and fungi in the soil. It now transpires that Agrobacterium can enlarge their host range to infect other species and exchange genes with them through hormones produced at the site of plant wounds ([9] Scientists Discover New Route for GM-gene 'Escape', SiS 50).

Pollen spread

The applicant has indicated that they are not aware of any commercial plantings of sexually compatible Eucalyptus species within 1 000 meters of the proposed test plot location at any of these sites. Therefore, based upon the limited distance that viable pollen is likely to occur outside a tree stand, it is deemed highly unlikely that gene flow would occur outside of the confined field test sites at these locations.  An Australian study, however, found that remnant populations of Eucalyptus were connected by pollen dispersal to pollen sources up to 1.94 kilometers away [10]. 

It is by now obvious that transgenes can also spread horizontally to all species interacting with the trees and pollen, in the air, in the soil and in the water, as we have repeatedly pointed out to regulators [9].  Needless to say, horizontal gene transfer was dismissed.

Deadly yeast in Eucalyptus

Cryptococcus  neoformans gattii is a yeast pathogen hosted by a variety of Eucalyptus species as well as other tree species.  It causes systemic fungal infections in humans, leading to fungal meningitis and death.  C. neoformans gattii has been found on a number of Eucalyptus hosts, some being grown in commercial plantations and imported and exported for ornamental use. People have contracted and died from cryptococcosis in India, Africa, Taiwan, South America and California.  C. neoformans gattii infections are found particularly in AIDS patients due to their weakened immune systems. Infections with this fungus are rare in those with fully functioning immune systems. For this reason, C. neoformans gattii is sometimes referred to as an opportunistic fungus. There was an outbreak of cryptococcal disease on the eastern part of Vancouver Island, British Columbia in 1999. The disease was previously only known to occur in tropical or semi-tropical climates. The risk that these field trials will result in a higher incidence of the fungus in the US and thereby pose a risk to human health is considered negligible for the following reasons. First, there is not a clear association between E. grandis or E. urophylla and C. gattii. Second, there is no reason to believe that the genetic modification of the hybrids will alter the association of the trees with C. gattii. Third, the scale of the field tests is miniscule compared to the vast expanses of native trees that could potentially harbour the pathogen [2].

But there is already evidence among forest or urban trees that Eucalyptus species are homes for the deadly yeast.  Furthermore, there is no vast expanse of native species in the US that are homes for the toxic yeast, according to the peer reviewed scientific publications  [11-13]. The deadly yeast should have been studied in the transgenic trees rather than being groundlessly and a priori dismissed by USDA.

Issues raised in previous submissions on transgenic Eucalyptus still unresolved

The Institute of Science in Society  previously submitted several briefs objecting to environmental releases of GM Eucalyptus, and dealing with other issues in more detail, such as the alteration in susceptibility to disease or insects , the potential of the Eucalyptus to harbour plant pests, the kanamycin resistance selectable marker gene, the barnase gene, genes for altered lignin, and the deadly yeast C. gattii [14-15] Field Testing Genetically Engineered Eucalyptus: Environment Assessment Still Inadequate, SiS 46, GM Eucalyptus Environmental Assessment Irregular, SiS 35]. None of the issues we raised have been properly addressed, let alone resolved.

We can only repeat our call [16] for a Moratorium on all GM Trees and Ban on GM Forest Trees (SiS 35).

  1. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service  [Docket No. APHIS–2011–0130] ArborGen, LLC; Availability of an Environmental Assessment for Controlled Release of a Genetically Engineered Eucalyptus Hybrid  Federal  Register Vol.  77,  No.  28 Friday, February 10,  2012  Notices 7123.
  2. Eck C. Permit application 11-052-101rm received from ArborGen Field testing of genetically engineered Eucalyptus grandis X Eucalyptus urophylla Draft Environmental Assessment December 6, 2011
  3. Cummins J. Low lignin GM trees and forage crops. Science in Society 23, 38-39, 2004.
  4. Cummins J. Kanamycin still used and cross-reacts with new antibiotics. ISIS report, 27 May 2001,
  5. Navarro M, Ayax C, Martinez Y, Laur J, El Kayal W, Marque C, Teulières C. Two EguCBF1 genes overexpressed in Eucalyptus display a different impact on stress tolerance and plant development. Plant Biotechnol J 2011, 9(1), 50-63.
  6. Cummins J and Ho MW. USDA FONSI for transgenic poplars absurd & dangerous. Science in Society 38, 40-41, 2008.
  7. Ulyanova V, Vershinina V and Ilinskaya O. Barnase and binase: twins with distinct fates. The FEBS Journal 2011, 3633-43.
  8. Ho MW. Scientists discover new route for GM-gene ‘escape’. Science in Society 50, 14-16, 2011.
  9. Knight CJ, Bailey AM, Foster GD. Investigating Agrobacterium-mediated transformation of Verticillium albo-atrum on plant surfaces. PLOS ONE 2010, 5(10): e13684. Doi:10.1371/journal.pone.0013684
  10. Sampson JF, Byrne M. Outcrossing between an agroforestry plantation and remnant native populations of Eucalyptus loxophleba. Mol Ecol 2008, 17(11), 2769-81.
  11. Chen M, Liao WQ, Wu SX, Yao ZR, Pan WH, Liao Y. Taxonomic analysis of cryptococcus species complex strain S8012 revealed Cryptococcus gattii with high heterogeneity on the genetics. Chin Med J (Engl). 2011, 124(13), 2051-6.
  12. Chowdhary A, Randhawa HS, Boekhout T, Hagen F, Klaassen CH, Meis JF. Temperate climate niche for Cryptococcus gattii in Northern Europe. Emerg Infect Dis. 2012, 18(1), 172-4. doi: 10.3201/eid1801.111190
  13. Crous PW, Groenewald JZ, Shivas RG, Edwards J, Seifert KA, Alfenas AC, Alfenas RF, Burgess TI, Carnegie AJ, Hardy GE, Hiscock N, Hüberli D, Jung T, Louis-Seize G, Okada G, Pereira OL, Stukely MJ, Wang W, White GP, Young AJ, McTaggart AR, Pascoe IG, Porter IJ, Quaedvlieg W. Persoonia 2011, 26, 108-56.
  14. Cummins J.  Field testing genetically Engineered Eucalyptus: rnvironment assessment still inadequate.  Science in Society 46, 36, 2010.
  15. Cummins J and Ho MW. GM eucalyptus environmental assessment irregular. Science in Society 35, 50, 2007.
  16. Cummins J and Ho MW. Moratorium on all GM trees and ban on forest trees. Science in Society 35, 32-34, 2007.

Reposted from:

by Rob

Posted by Rob on March 22, 2012 in Ecological/Cultural Sustainability, Oil Crops, Regulatory Issues, Safety/Toxicity, Science | Permalink | Comments (0) | TrackBack

December 12, 2011

Lavender oil and negative innuendo

by Robert Tisserand

In a recent blog post an Environmental Working Group (EWG) research assistant suggests that lavender oil may be unsafe, saying: “the science is still evolving and safety can’t be assumed.” The science is still evolving? Isn’t that true of anything? Are we just sowing the seeds of doubt here?

I have written a number of posts about the EWG and sloppy science. Their modus operandi involves highlighting negative information, along with liberal use of the phrase “has been linked to”. Facts are so often distorted that their reputation in scientific circles is all but worthless. I have never read an EWG report in which both sides of an argument are presented. The problem I have with this approach is that the EWG audience is consumers, who have neither the scientific training nor the knowledge and expertise to challenge what is being said. In spite of this many do, because they instinctively feel that something is not right.

Skin allergy
Lavender oil “has been linked to” allergic reactions, it’s true. But how strong is that link? After all, if you look hard enough, you will find at least one allergic reaction report for almost every substance used in cosmetics. Cherry picking a few negative studies is not a useful way to help consumers assess product safety. What we need is a comparative rating that clearly flags high-risk ingredients, along with practical safety guidelines.

“Allergy epidemics” have occurred in the past, most often with preservatives. As use becomes more extensive, adverse reactions escalate, and eventually the substance is either banned or restricted. In spite of widespread use, this is not happening with lavender, which has been the most popular essential oil for aromatherapy use since the 1970s.

The EWG post is written by Swati Sharma. She tells us that: “Despite its ubiquity in cosmetics, researchers in Japan who compared eight essential oils found that lavender caused the greatest number of skin allergies.” No it did not, unless you only look at two of the nine years of the study! The Japanese researchers tested six essential oils, one absolute and two essential oil constituents. The essential oil that produced the most adverse reactions was ylang-ylang (tested at 5%), followed by geranium (tested at 20%) followed by lavender (also tested at 20%). And since all the other substances were tested at either 5% or 2%, the relative risk of each cannot be compared anyway. The higher the test concentration, the greater will be the number of reactions. And, the Japanese subjects were all dermatology patients “suspected of cosmetic dermatitis”, an especially high-risk group.

Considering that the lavender oil was patch tested at 20% in a high-risk population, and that only 1.4% (21 of 1,483) of patients had an adverse reaction, this does not suggest a significant allergen. Other research points to lavender oil presenting a very low risk. When 50 healthy volunteers were patch tested with the undiluted oil, there were no reactions (Meneghini et al 1971). Similarly, none were produced in 25 volunteers tested with lavender at 10% (Opdyke 1976 p451). In a study of 200 dermatitis patients in Poland, none were sensitive to 2% lavender oil (Rudzki et al 1976). In a Danish study, two of 217 dermatitis patients (0.9%) tested positive to 2% lavender oil (Veien et al 2004). Tested at 1%, lavender oil produced no reactions in 273 dermatitis patients (Meneghini et al 1971).

Taken together, these results show that two of 690 dermatitis patients (0.3%) reacted to lavender oil when patch tested at 1% or 2%. However, extrapolating from patch test data on dermatology patients to the general population is notoriously difficult (especially since the conditions of patch testing exaggerate risk) and the actual number of people with adverse reactions to lavender is very much less than 0.3%. Over a 15 year period (1986-2000) there have only been five cases of lavender oil allergy reported worldwide (Brandão 1986, De Groot 1996, Keane et al 2000, Schaller & Korting 1995, Selvaag et al 1995) and three were people with multiple allergies. This is in contrast to millions of bottles of undiluted lavender oil being sold to consumers per annum, and millions more personal care products containing lavender oil.

From all of the above we can conclude that a 20% concentration of lavender oil might be risky for Japanese consumers with cosmetic allergies, but 2% is not a risk to anyone, and even undiluted lavender is safe to use on healthy skin. Not only is lavender a very low-risk skin allergen, it possesses anti-allergic properties. Topically applied, the oil inhibited immediate-type allergic reactions by inhibiting the release of histamine from mast cells (Kim et al 1999). How is this possible? Probably because in most cases, allergies only occur from the use of oxidized lavender oil. The unoxidized oil is anti-allergic, and is even moderately antioxidant (Wei and Shibamoto 2007).

Sharma tells us that linalyl acetate, a major constituent of lavender oil, can oxidize in the presence of atmospheric oxygen, “forming allergens that can cause contact dermatitis” (Sköld et al 2008). Indeed it can, as can linalool, the other major constituent of lavender oil (Sköld et al 2004). However, these are theoretical risks, not actual risks, and lavender oil oxidation is a process that takes many months, even years. What this research suggests is that products containing lavender oil should be protected from oxidation by the addition of antioxidants, and that very old products should be discarded. The International Fragrance Association (IFRA) does not have a regulation for lavender oil, but it does for linalool. Referring to linalool-rich essential oils, the IFRA guideline recommends the addition of an antioxidant: “The addition of 0.1% BHT or a-tocopherol has shown great efficiency” (IFRA 2009).

Next, Sharma informs us that “lavender oil may be toxic to human skin cells” though curiously no reference is given (it’s Prashar et al 2004). I addressed this issue in a previous post about lavender, in which I explain how we know that the oil is not a skin irritant, and is not toxic to skin cells when applied to human skin.

Hormone disruption
Finally, Sharma raises the question of lavender oil and hormone disruption, an issue I have also addressed previously, in this article. To sum up, there was no established link between lavender oil and breast growth in three pre-perbertal boys, but lavender oil did show a weak in vitro estrogenic action in two (of the four possible) types of in vitro test for estrogenic activity (Henley et al 2007). None of this establishes that lavender oil disrupts hormones. To quote Diel et al (1999): “…even a combined use of several in vitro test systems is not able to predict the occurring action of a substance in the organism.” In other research, lavender oil was significantly toxic to human breast cancer cells (Zu et al 2010) suggesting that it would prevent breast cancer, and not increase risk.

Summary points
Consumer products containing lavender oil may benefit from the addition of an antioxidant, such as alpha-tocopherol. This should be used at 0.1-0.2% (note that using more is not more effective).

Bottles of lavender oil, or products containing lavender oil, that are more than 12 months old (after first use) should be discarded if they no longer smell fresh.

There is a theoretical risk of skin allergy from lavender oil, but this risk is extremely low. Restricting the percentage of lavender oil in leave-on products (skin creams, lotions, gels) to 2% would be over-cautious, but combined with the addition of an antioxidant, will make a product super-safe.

Lavender oil has a weak in vitro estrogenic activity, but there is no reason to believe that this translates to a hormone-disrupting effect in humans.

Brandão FM 1986 Occupational allergy to lavender oil. Contact Dermatitis 15:249-250

De Groot AC 1996 Airborne allergic contact dermatitis from tea tree oil. Contact Dermatitis 35:304-305

Diel P, Smolnikar K, Michna H 1999 In vitro test systems for the evaluation of the estrogenic activity of natural products. Planta Medica 65:197-203

Keane FM, Smith HR, White IR et al 2000 Occupational allergic contact dermatitis in two aromatherapists. Contact Dermatitis 43:49-51

Henley DV, Lipson N, Korach KS et al 2007 Prebubertal gynecomastia linked to
lavender and tea tree oils. New England Journal of Medicine 365: 479-485

IFRA 2009 Standards, including amendments as of October 14th 2009. International Fragrance Association, Brussels.

Kim HM, Cho SH 1999 Lavender oil inhibits immediate-type allergic reaction in mice and rats. Journal of Pharmacy & Pharmacology 51:221-226

Meneghini CL, Rantuccio F, Lomuto M 1971 Additives, vehicles and active drugs of topical medicaments as causes of delayed-type allergic dermatitis. Dermatologica 143:137-147

Opdyke DL 1976 Monographs on fragrance raw materials. Food & Cosmetics Toxicology 14 supplement

Prashar A, Locke IC, Evans CS 2004 Cytotoxicity of lavender oil and its major components to human skin cells. Cell Proliferation 37:221-229

Rudzki E, Grzywa Z, Brud WS 1976 Sensitivity to 35 essential oils. Contact Dermatitis 2:196-200

Schaller M, Korting HC 1995 Allergic airborne contact dermatitis from essential oils used in aromatherapy. Clinical & Experimental Dermatology 20:143-145

Selvaag E, Holm JO, Thune P 1995 Allergic contact dermatitis in an aromatherapist with multiple sensitizations to essential oils. Contact Dermatitis 33:354-355

Sköld M, Börje A, Harambasic E et al 2004 Contact allergens formed on air exposure of linalool. Identification and quantification of primary and secondary oxidation products and the effect on skin sensitization. Chemical Research in Toxicology 17:1697-1705

Sköld M, Hagvall L, Karlberg AT et al 2008 Autoxidation of linalyl acetate, the main component of lavender oil, creates potent contact allergens. Contact Dermatitis 58:9-14

Sugiura M, Hayakawa R, Kato Y et al 2000 Results of patch testing with lavender oil in Japan. Contact Dermatitis 43:157-160

Veien NK, Rosner K, Skovgaard GL 2004 Is tea tree oil an important contact allergen? Contact Dermatitis 50:378-379

Wei A, Shibamoto T 2007 Antioxidant activities and volatile constituents of various essential oils. Journal of Agricultural & Food Chemistry 55:1737-1742

Zu Y, Yu H, Liang L et al 2010 Activities of ten essential oils towards Propionibacterium acnes and PC-3, A-549 and MCF-7 cancer cells. Molecules 15:3200-3210

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

Posted by Blogmistress on December 12, 2011 in Aromatherapy, Cosmetics, Lavender/Tea Tree/Gynecomastia, Safety/Toxicity, Science | Permalink | Comments (4) | TrackBack

July 07, 2011

Déjà vu–It’s Still NO To SCA 2011 (HR 2359)

Dia de los Muertos3The so called “Safe Cosmetics Act” has been rolled out again, with even more attendant shock and awe PR from the misguided zealots at the Campaign for Safe Cosmetics using misinformation on  Environmental Working Group’s Skin Deep Database.  If one were to rate the importance of this bill . . . what with a fragile economy in slow recovery, an unemployment rate stuck at over 9%, entire states in disarray (WI) or in near-complete shutdown (MN),  so many environmental catastrophes (Exxon-Mobil/Yellowstone River Spill) or near catastrophes (Las Alamos National Laboratory Site Fire), (Nebraska Nuclear Power Plant Missouri River Flood) . . . it logically would be of low priority. To me, there appears to be so much more urgency to address myriad larger problems facing the Nation, I sometimes feel like Atlas with that giant granite weight crushing any hope that used to glimmer that our elected leaders are going to stop their partisan bickering and get on with the business of governing and helping remedy the continuing effects of a massive economic recession.  I put the importance of HR 2359 at about a –minus –minus –minus ridiculous number.  I don’t know about you, but I would much prefer our lawmakers to be focusing their time and efforts on some of these macro issues desperately in need of their attention.  You know, like making sure our kids can go to school 5 days a week instead of the 3 or 4 now having to be imposed because of necessary budget cuts in many states.  Hello!  That’s surely going to help regain academic status in the world, isn’t it, and perhaps not possibly lose an entire generation to ignorance?  And you can be damned sure my colleagues and I have more important things to do than weed through a poorly written bill, obviously crafted by those with little or no knowledge in the multiple scientific disciplines necessary to understand the minutia of cosmetic formulation, and especially pertaining to essential oils and natural plant extracts – the very ingredients consumers most want in their natural personal care products.

Samara Botane/Nature Intelligence opposes Safe Cosmetic Act 2011 (HR 2359).  

As much as I and many other colleagues in the personal care, spa, herbal, natural perfume and aromatherapy industries may wish it weren’t so, we are once again faced with having to raise our small voices to defend the integrity of our professional pursuits to bring safe, effective personal care products into the marketplace . . . to avoid unnecessary, sometimes impossible regulations that are not going to make cosmetics any safer than they are now and only raise consumer prices because of the additional money, time and effort to comply.  

Never mind that, when this bill was first introduced in 2010,  we have previously pointed out that lead has not purposefully been added to lipstick by unscrupulous manufacturers gleefully twirling their mustaches, and that it naturally occurs as an element of the Earth’s surface and is in EVERYTHING in microscopic amounts, especially natural botanical ingredients.  It is in your water.  How many times must one state a FACT before it is understood and accepted?  This is still one of CFSC’s major talking points.  It has grown to epic proportions and wends its way into many lists of toxins to avoid, such as Green America’s 9 Toxins to Avoid in Personal Care Products, a document not referenced nor annotated with any scientific substantiation.  Those inclined to do more research on this matter would quickly find “Easily Led” a comprehensive thorough investigation of the claim (now urban legend), ending with the caveat, “The bottom line is that U.S. medical literature has yet to record a single case of anyone’s coming down with lead poisoning through lipstick use.” Of course, the CFSC has  trotted out “Lead in Lipstick” in an attempt to overstate the danger  in a desperate, somewhat hysterical hue and cry that microscopic levels of lead in lipstick at the highest tested 0.00000306 are of sufficient danger to browbeat our legislative representatives once again to put forth a bill that will never make its way through the process to become law, as it is now written.  All of this frenzied PR hype (rolled out by CFSC before the bill was even publicly announced) cannot counter “A Perspective on the Safety of Cosmetic Products: A Position Paper of The American Council on Science and Health”.   Nor can it counter the response from the Personal Care Products Council in 2010, nor their current response.  If you’d like pleasantly-presented, factual, scientific based information on cosmetic safety, PCPC has produced this series of short videos for the consumer. You can search this site for a specific ingredient or browse by product category. If you are looking for an easily-searched, more scientific database, try Toxipedia, where you will find no alarming leading questions like “Are you sure about your lotion?” or untrue statements like “Most sunscreens aren’t safe.” such as are found on EWG’s Skin Deep.  You will also not be subjected to a ineffective numerical rating system for product hazard, just scientific research and facts, no opinion . . . how refreshing.

Never mind that we have carefully critiqued and debunked Annie Leonard’s cleverly crafted propaganda video “The Story of Cosmetics” as the supreme shock and awe scare tactic hype it is.  Oh, but it’s cute, and cute appears to trump rational fact and common sense these days.  The sad thing is that the frenzied imagery of a masked assembly line worker purposefully inserting poison (international skull and cross bones = SCARY) into a cosmetic container, followed by the same skull and crossbones ruthlessly stamped on a baby (even more SCARY) in the bathtub does not seem to invigorate the critical thinking necessary to separate fact from overblown fiction.  And, this fictional video seems to incite, rather than inform those not capable of critically assessing information by comparing with credible reference and countering  professional opinion. How sad.

Examine the current FDA Authority Over Cosmetics and you will see it is comprehensive.  It is true that there are issues of concern to be addressed.  I believe the FDA will continue to do due diligence to insure the safety of cosmetic products.  I believe that the industry will be more than willing to assist this effort and comply with reasonable regulations.  HR 2359 is not the answer.  At this time when we have so many stressful  problems facing us, let us focus on what is urgent and necessary.

Please join me in opposing HR 2359 by signing the petition.

Posted by Blogmistress on July 7, 2011 in Cosmetics, Regulatory Issues, Safety/Toxicity | Permalink | Comments (1) | TrackBack

July 06, 2011

Ten reasons why you should not support SCA 2011

The Environmental Working Group, who have given birth to this legislation, is an incompetent organization that does not understand the science of toxicology, does not understand natural products, and that takes a biased, negative view of safety, often seeing dangers that do not exist.

  1. SCA 2011 requires that all ingredients of ingredients must be declared on product labels or company websites (where labels are not large enough). This unfairly targets companies that make natural products. A product containing several herb extracts and/or essential oils will have an ingredient list with thousands of ingredients. This will make reading ingredient lists harder for consumers, not easier.
  2. Unlike some other safety regulations, SCA 2011 does not distinguish between a naturally occurring substance (such as an ingredient of a herbal extract) and the intentional addition of a synthetic chemical. The end result of this will be that many herb extracts and essential oils will no longer be permitted as cosmetic ingredients as has already happened in Europe.
  3. SCA 2011 requires that “contaminants” (the word is not defined anywhere in the bill) that are present in a cosmetic at one part per billion or over be declared on the ingredients list. This expectation is naïve, unnecessary and impractical. Even pharmaceuticals are not regulated to such a degree.
  4. SCA 2011 requires a safety standard for cosmetics that is defined as a risk not greater than one in a million. Demonstrating this conclusively would, by definition, require testing on millions of either animals or humans. This is similarly naïve, unnecessary and impractical but if enforced, would mean that there will be no cosmetics, because it is an unreachable standard.
  5. The above safety standard is specifically stated to include all “vulnerable populations” including a sick person with a compromised immune system, someone with asthma, and a newborn infant. Every cosmetic produced has to present zero risk to every human being. However, zero risk is a fantasy of the EWG – it does not exist on planet Earth.
  6. Even though the bill includes a clause about alternatives to animal testing, the stipulations of SCA 2011 for safety testing for carcinogenicity and reproductive toxicity will necessitate the deaths of thousands of animals because there are as yet no viable substitutes for these two toxicity tests.
  7. The massive amount of new testing proposed by SCA 2011, and all the attendant administration will cost billions of dollars. One way or another, this cost will be passed on to consumers. This is not the time to be spending this kind of money on unnecessary legislation.
  8. The amount of checking, testing, listing, re-designing, re-formulating, re-printing and form-filling would be a massive burden to cosmetics companies. Some, both large and small, will go out of business, with attendant job losses.
  9. Labeling regulations are already onerous for any company selling internationally. Since the labeling requirements of SCA 2011 are not in line with those of any other country or region, this will create chaos in the industry.
  10. Although SCA 2011 delegates authority to the FDA, it also allows for any “responsible party” to file a claim that a product may cause serious adverse health effects. This is the EWG giving itself the power to endlessly pursue products or companies that it does not like.

Cosmetics safety regulations in the USA could be improved, but this is not the answer. It is over-reaching, unworkable and unnecessary.

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

Posted by Blogmistress on July 6, 2011 in Cosmetics, Organizations, Regulatory Issues, Safety/Toxicity | Permalink | Comments (0) | TrackBack

June 22, 2011

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

Coriandrum sativum

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.

Linalool table

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

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.

Lemon 500x332On 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.

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
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.

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.

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.”

Abdominal injectionMediumThis 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.

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.

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.

Posted by Blogmistress on June 22, 2011 in Aromatherapy, Essential Oils/Plant Extractions, Organizations, Regulatory Issues, Research, Safety/Toxicity, Science | Permalink | Comments (0) | TrackBack

March 01, 2011

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.

Posted by Rob on March 1, 2011 in Aromatics in Print, Essential Oils/Plant Extractions, Safety/Toxicity | Permalink | Comments (0) | TrackBack

August 17, 2010

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, 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.

olives“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.

In health news...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.


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

Posted by Blogmistress on August 17, 2010 in Cosmetics, Essential Oils/Plant Extractions, Regulatory Issues, Safety/Toxicity | Permalink | Comments (2) | TrackBack