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

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

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.


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

August 09, 2010

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

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

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

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

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

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

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

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

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

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

Posted by Blogmistress on August 9, 2010 in Aromatherapy, Essential Oils/Plant Extractions, Massage, Perfumery, Regulatory Issues | Permalink | Comments (3) | TrackBack

July 08, 2010

The Revealing Truth of the Money Trail of EWG

by Kayla Fioravanti, reprinted with permission.

With every stand that you take there are those that will stand with you, those that will digest the information and think about it and others who will take a stand against you.  I know that is a risk that I took when I chose to publicly stand against the Environmental Working Group (EWG) and their Skin Deep Database.


I debated posting what I found after I followed the money trail, since just my mention on social media that I was doing the research lost me a customer.  I'd prefer to remain neutral, but I fear that neutrality would result in continued damage to small businesses around the country by an organization that sadly lacks the science to back up their claims.  Being outspoken against the EWG may continue to cost me some customers, but I believe education is the key to fact based decisions and safe cosmetics.

In the past few months I have been terribly disturbed to see the Environmental Working Group send repeated emails requesting just another $10 donation.  Each letter sounds more dire than the next as if the world would literally end if the EWG didn't meet their budget. 

This inspired me to do a little digging to see just what Mr. Cook himself makes annually since he was making the earth shattering pleas for donations.  The only 990 I could get a hold of for the EWG was 2008

According to BA Carrington with Empowerment Enterprises, LTD, "They (EWG) have not filed a tax return on the 501 c 3 since 2008, according to the 990 database Exempt World, which is a subscription service to track 990’s.  Even though EWG is categorized as a charitable organization, it is still required to file a return under IRS codes and submit their “list of activities” to the IRS on an annual basis, even if they file an extension."  It could be that they have filed an extension and the deadline for the information has not yet passed based on their calendar fiscal year.  For more details on this possibility click here

The EWG has stepped up it's fundraising to now include promoting the purchase of the very same sunscreens that they claim are bad for you through Amazon to raise money for the EWG.  Read more about that topic click here.

According to 2008 IRS Tax Filings

In 2008 Ken Cook was paid $219.401.00 plus another $21,295.00 estimated amount of other compensation from organization and related organizations. 

Richard Wiles $179,218.00 plus $20,998.00 estimated amount of other compensation from the organization and related organizations. 

Jane Houlihan $150,226.00 plus $19,448.00 estimated amount of other compensation from the organization and related organizations. 

William Walker made $136,448.00 plus 19,743.00 estimated amount of other compensation from the organization and related organizations.

Susan Comfort $115,752.00 plus $7932.00 estimated amount of other compensation from the organization and related organizations.

Sandra Schubert $127,229.00 plus $4884.00 estimated amount of other compensation from the organization and related organizations.

Alexander Formuzis $120.592.00 plus $10,920.00.  Christopher Campbell $136,909.00 plus $11,988.00 estimated amount of other compensation from the organization and related organizations.

Breaking it all Down

In case you got sick of reading the pay that is a total of $1,185,775.00 being paid to the top 8 employees of the Environmental Working Group just in 2008.  The total estimated amount of other compensation from the organization or related organizations for the top 8 at EWG was $117,248.00.  The total reported 2008 salaries for EWG was $3,203,747.00 in 2008.  The 2008 total revenue at EWG was $6,242,570.00.  Over half of their total revenue went into paying the employees of EWG. 

I am not opposed to making a profit.  I believe in Capitalism.  I also appreciate that it takes time, money and resources to pursue any public policy position. But still, more than half of the operating budget is a lot.  I am troubled when a non-profit that asks for $10 via email and $5 most of the time you click on their Skin Deep website as if they are on the verge of going out of business is spending so much of your money on their executives. 

In 2006 Ken Cook was reported to have been paid $192,000.00.  If Ken Cook continued at the same rate of pay increase over the past two years as he did from 2006 to 2008 he may be making as much as $245,000.00 (only an estimate based on the pay rate of increase from 2006 to 2008).

No wonder I get so many requests for another $5 or $10 donation from the EWG. At 2008 pay rates they need at least 118,578 people to donate $10 just to cover their top 8 executives pay...who knows how much is needed to cover it in 2009 and 2010?!

You have to wonder if the EWG is really hurting for money or if they just like to keep their budget at a certain number.  In 2008 the net assets or fund balances were $5,171,374.00 at the end of the year.  They were given gifts, grants, contributions and memberships fees in 2004 of $4,975,899.00, 2005 of $3,539,214.00, 2006 of $3,478,044.00, 2007 of $4,004,846.00 and 2008 another $5,963,800.00. 

A very revealing, carefully documented and thoroughly research of the history of and who is behind the EWG can be found on the Personal Care Truth website (click here to read.)

The EWG, Skin Deep and the Campaign for Safe Cosmetics have made many claims that cosmetic companies are financially driven to claim that ingredients are safe, I am simply wondering if EWG has a financial interest in saying that they are not safe.  I don't know many small business cosmetic owners who are making as much money as the top 8 at EWG. 

I'm just this economy do they really need your $10?  What do you think?  Does knowing the money trail color your impression of the EWG as a non-profit?

Kayla Fioravanti and her husband Dennis own and operate Essential Wholesale

Ed. note: After reading Kayla’s excellent report and the comprehensive history at Personal Care Truth, as well as examination of available information  on the EWG website and other sources, several red flags wave.  These include, but may not be limited to, proportional ratio of administrative salaries vs. actual program funding; lack of transparency of donors as well as staffing and operations; unclear financial and staffing relationship between EWG and EWG Action Fund.  In 2002 an IRS complaint was filed against EWG asking for an investigation and revocation of their nonprofit status.  Further research is needed to establish the determination of that action.

Posted by Blogmistress on July 8, 2010 in Cosmetics, Organizations, Regulatory Issues, Safety/Toxicity, Science | Permalink | Comments (0) | TrackBack

June 10, 2010

The Elephant in the Room: That ‘Not So Sexy’ CSC Report…

Copyright © Tony Burfield June 2010


For some time Cropwatch has been maintaining that the cosmetic (fragrance) industry, the detergent & cleaning industry & the aroma ingredients (essential oil) industry suffer disproportionate and wildly over-precautionary levels of regulation in the EU, compared with other industrial sectors, such as agri-business, pharmaceuticals or food & beverages. Wherever Cropwatch has lectured, everybody has strongly agreed with the word ‘disproportionate’. And, as we have previously argued, we can point to tens of thousands of premature deaths amongst health patients from adverse drug reactions arising from prescribed drugs, but it is hard to find more than a handful of clinically referred cases of, say, acute contact dermatitis amongst the hundreds of millions of fragrance users, let alone a single instance of a death. Safety has become some high altar on which career toxicologists & regulatory officials (read: lawyers) are free to dispatch the products of hapless aroma ingredient producers to the graveyard, often on the flimsiest of toxicological evidence, to the detriment of the industry’s standards and levels of attainable perfumery excellence. Yet, apparently, none of these considerations with respect to perfumery as a damaged heritable art-form, seem to count for very much amongst the fragrance industry’s bean-counters, living in fear of media exposure and therefore loss of profit arising from the use of a perfumed commodity which contains some allegedly hazardous material.

Just as the EU Commission’s lawyers were persuaded in the 1990’s that an allergy epidemic was occurring in Europe, and Danish dermatologists and others were pointing their fingers at fragrance chemicals as a contributory factor, so we were catapulted into the inappropriate and unnecessary regulation of allergens in cosmetics in 2003 (the ‘26 Allergens Fiasco’ – see Cropwatch website). The story now given (e.g by Vey 2010) is that the incidence of allergy is presently estimated as some 9 times lower since then – difficult for me personally to swallow, but on the other hand I could believe that the clinical assessment of suspected allergy has since improved nine-fold – especially as Cropwatch has seen confidential documents from 1998 describing the shortcomings of commercial Fragrance Mix Allergy Kits used by professional dermatologists & clinicians (including the fact that the oakmoss ingredient used for allergy testing was unforgivably not genuine oakmoss!). As you will undoubtedly have gathered, restriction to the unfettered use of perfume ingredients (especially to essential oils) caused by the ill-advised EU Directive 2003/15/EC, which severely limited the concentration of alleged allergens in cosmetic products, is damage we are still trying to undo. In any fair society, something would be done, in the light of evidence that many of the alleged allergens listed are so weak or inactive that they do not produce significant levels of adverse reactions, even in patients with dermatological problems (see Schuch 2007). But it seems impossible that the ‘expert’ advisers concerned (the SCCNFP) can bring themselves to admit that they have collectively made some serious mistakes.

The ‘Not So Sexy’ CSC Report

But now history looks as if it might repeat itself, this time in the US, in yet another wave of chemophobic paranoia over fragrance chemicals. Of course, the fact that many of us might not be in absolute tip-top condition has nothing to do with bad diet, over-eating/excessive bodyweight, excessive consumption of alcohol and/or cigarettes, lack of exercise, recreational drug-taking, breathing in diesel-polluted air or anything remotely similar. Oh no. According to some, it is because, apparently, we are all being poisoned by our fragranced cosmetics. The reality is, of course, that we live in a period where cosmetics are over-safe - as soon as arsenic compounds were removed from face-powder, and musk ambrette from joss-sticks, the chances of rigor mortis setting in some after a squirt of whatever perfume some Z-list celebrity is currently promoting became pretty negligible. If you really want to know what might keep me awake at night, it is certainly not what micro-quantities of polycyclic musks might be accumulating in my body tissues from use of my personal deodorant, or how much methyl eugenol I consumed in my pesto-laden mozzarella sandwiches that day, but how many hot particles I might have stumbled into on my local beach, because the UK nuclear industry has previously seemed to be unable to keep the all of its americium & plutonium within the plant’s secondary containment!

Anyway back to the main story. As I said in my address to the World Perfumery Congress (WPC) 2010 in Cannes – see Burfield at Cannes 2010.ppt - the US cosmetics industry's self-regulatory approach and lack of ingredient safety substantiation has not been without its critics, such as the increasingly influential environmental organisational groups of the Environmental Working Group (EWG), Skin Deep & The Campaign for Safe Cosmetics (CSC). The CSC’s commissioned report “Not So Sexy - The Health Risks of Secret Chemicals in Fragrance” (CSC 2010) produced by Commonweal, Environmental Working Group, Breast Cancer Fund, Women’s Voices for the Earth & Anne Steinemann (University of Washington) amongst others, certainly caused a lot of comment amongst delegates at the WPC 2010. Delegates seemed mainly concerned that the sensationalist presentation style of the report, the unsubstantiated innuendo, the biased and unrepresentational selection of toxicological evidence, coupled with the evidential lack of rationalised scientific overview, may lead many less well-informed people to link fragrance chemicals with adverse health effects – an undeserved conclusion considering the lack of direct evidence presented in the report. What Cropwatch found particularly surprising was the idea that the public would fall for the supposedly “secret ingredients” claim – i.e. the non-listing of fragrance ingredients which are not required to be shown on the product labelling under existing legislation, agreed in order to protect the intellectual property rights of the fragrance producer. We are not saying this is non-consequential, but, for example, it has been shown that for those substances currently requiring mandatory labelling in Europe (such as the chemical names of allergens on the labels of UK supermarket cleaning products), there has been almost zero levels of comprehension and near-zero levels of interest from prospective customers.

Some of the fragrance ingredients identified in the CSC report are anti-oxidants or UV-stabilisers, deliberately added to the product to prevent the (unlikely) generation of sensitisers from ingredients such as limonene and linalol - a fact which weakens the CSC argument surrounding sensitisers. The relative stability of linalol and its incorrect classification as a sensitiser, for example, is well-known (Hostynek & Maibach 2008), but the CSC failed to reveal this fact in their report. Yet other ‘secret’ substances identified (alpha-pinenes, myrcene, limonene, gamma-terpinene, para-cymene, terpineol (no isomer stated) and alpha-cedrene) are all components of forest air and of natural essential oils. Millions of tons of monoterpenes, including alpha-pinene and limonene, are passed into the atmosphere per annum from biological materials (Schenk 1979, WHO 1998) for example from green leaves & therefore the needles of pine, fir, spruce & cedar trees, to an extent that both latter substances have been identified in human breast milk – but their presence has raised no public outcry (as opposed to the presence of musks). Maubert (2007) notes that the Landes Forest in SW France produces more terpenes per month than Europe’s entire consumption of essential oils in a year. So shouldn’t the CSC rather be identifying trees and forests as their imagined toxicological threat?

Other materials identified in the report (phenylethyl alcohol, benzyl acetate, benzyl salicylate, benzyl benzoate, linalyl acetate, hexyl acetate) occur in essential oils, absolutes & resinoids, and in the natural emissions of plants and flowers, although it is apparent from the text that the authors may not collectively realise this fact in all cases. It would be exceedingly unfortunate if this pressure group succeeded in bringing in restrictive legislation against these ingredients. Since legislators treat natural and synthetic forms of ingredients equally, any such restrictive legislation would have implications for the lifestyles of many of CSC’s supporters who may like to regularly use natural materials in their daily lives (essential oils, natural perfumes, aromatherapy products, natural cosmetics, natural soaps etc.). Greenpeace made much the same mistake some years ago in arguing for the REACH legislation to be brought into effect in Europe. Thanks to their support for the legislation, and their failure to help lobby for the exclusion of natural aromatic substances, we now face the disappearance of many familiar aromatic materials, unless the aroma industry can cough-up the truly extortionate toxicological testing fees required for each ingredient.

More surprising is the lack of IT knowledge collectively shown by the CSC report’s authors (i.e. how to go about accessing comprehensive toxicological data from the internet or from scientific libraries – the authors seem to have mainly relied on PubMed!), and the low level of analytical competence shown in the analysis of the chosen fragrances, which operates well below industry standard. Employing a couple of teenagers and giving them access to the internet for a few `weeks should solve the first problem, and paying a $100 dollars or so a time to a small perfume company for GC-Mass Spec analyses of the fragrances that they are interested in, should solve the second. At least they should then get detailed & dependable analyses of the fragrances, which clearly they haven’t achieved so far (in Cropwatch’s opinion) looking at the paucity of detail in the presented results.

In the “what you can do” summary section of a review of the CSC report on the CSC website at you are be urged to lobby to “pass laws that shift the entire industry to non-toxic ingredients and safer production.” Since most/practically all natural products now carry some sort of (so-called) hazard labelling or risk phrasing, this effectively means shifting to the world of “safe” synthetics. Since the EU Cosmetics Commission is also dedicated to the establishment of a synthetic world which is safer than nature (Burfield 2010), so perhaps they would both like to lock themselves permanently away in it? Just leave the real world to us non-paranoid inhabitants please, so we can enjoy it in all its alarming chemical dangers – alcoholic drinks, herbs & spices, pesto, trees, flowers and, err, … fragrance!

The CSC report has been rebuffed in part by the Fragrance Manufacturing Association (FMA 2010) and IFRA. What is really needed, Cropwatch feels, is a line by line dissection of the whole 46-page report, refuting or challenging every erroneous or unproven statement made - otherwise the defence of fragrance chemicals is not adequately proven.

In Conclusion

Yes, of course it is right that consumer groups ask serious questions of the somewhat secretive fragrance industry. And its right that the FMA and the multi-million dollar IFRA organisation should respond with a highly detailed reply to all their points (N.B. a detailed reply is presently lacking). Its just a pity that the CSC have blundered in with such an accusatory and unscholarly document which may yet mess it up for all of us (for reasons stated above) – since - in spite of its scientific inaccuracy and unsubstantiated innuendo, the report will undoubtedly add more pressure to further regulate an already over-regulated industry.


Burfield T, (2010) – see Slide 14 at Burfield at Cannes 2010.ppt

CSC (2010) – see

FMA (2010) “U.S. Fragrance Association Finds New Cosmetics Report Misleading – Fragrance Safety Is No Secret” May 13th 2010

Hostynek J.J, & Maibach H. (2008) “Allergic Contact Dermatitis to Linalool” Perfumer & Flavourist 33(5), 52-56.

Maubert C. “The Naturals Paradox” World Perfumery Congress 2007 Booklet presented by Perfumer & Flavourist 2007,

Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) “Sensitization to 26 fragrances to be labelled according to current European regulation. Results of the IVDK and review of the literature.” Contact Dermatitis 57(1),1-10.

Shenck G.O. (1979) Perf Kosm 60, 397.

Vey M. (2010) - remarks made during the address to the Safety Symposium, British Society of Perfumers, Cambridge Belfrey Hotel, Mar 2010.

WHO (1998) Concise International Chemical Assessment Document No 5. Limonene. International Programme on Chemical Safety.


Posted by Tony Burfield on June 10, 2010 in Perfumery, Regulatory Issues, Safety/Toxicity | Permalink | Comments (2) | TrackBack

April 16, 2010

“Safe Chemicals Act of 2010”

Joined by Congressmen Henry Waxman and Bobby Rush, New Jersey Senator Frank Lautenberg introduced new legislation that would overhaul 1976 polyester era Toxic Substances Control Act.

"This is a complex issue, and we compliment Senator Lautenberg and Congressmen [Henry] Waxman and [Bobby] Rush for bringing focus to the need for modernization of the TSCA," said Cal Cooley, president of the American Chemistry Council, in a statement.

“Green groups would say that's an understatement. The TSCA grandfathered in more than 60,000 industrial chemicals that were already in use in 1976, with no safety testing, including chemicals like bisphenol-A, the endocrine disruptor that more recent studies have shown could have a serious impact on developmental health. New chemicals went straight to the marketplace with little government oversight — in the 34 years since the TSCA was enacted, the EPA has required testing for only 200 chemicals out of the more than 80,000 available for use in the U.S., and has regulated only five”, reports Time  Read more.

Press Release of Senator Lautenberg

Lautenberg Introduces "Safe Chemicals Act" to Protect Americans from Toxic Chemicals

Measure Will Require Safety Testing for Chemicals

Contact: Lautenberg Press Office (202) 224-3224
Thursday, April 15, 2010

WASHINGTON, DC - U.S. Senator Frank R. Lautenberg (D-NJ) today announced legislation to overhaul the “Toxic Substances Control Act of 1976” (TSCA), an antiquated law that in its current state, leaves Americans at risk of exposure to toxic chemicals. Lautenberg, who chairs the Senate Subcommittee on Superfund, Toxics and Environmental Health, introduced the “Safe Chemicals Act of 2010” to protect the health of families and the environment.
“America’s system for regulating industrial chemicals is broken,” said Senator Lautenberg. “Parents are afraid because hundreds of untested chemicals are found in their children’s bodies. EPA does not have the tools to act on dangerous chemicals and the chemical industry has asked for stronger laws so that their customers are assured their products are safe. My 'Safe Chemicals Act' will breathe new life into a long-dead statute by empowering EPA to get tough on toxic chemicals. Chemical safety reform is not a Democratic or Republican issue, it is a common-sense issue and I look forward to building bipartisan support for this measure.”
The “Safe Chemicals Act of 2010” requires safety testing of all industrial chemicals, and puts the burden on industry to prove that chemicals are safe in order stay on the market. Under current policy, the EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the United States and has been able to ban only five dangerous substances. The new legislation will give EPA more power to regulate the use of dangerous chemicals and require manufacturers to submit information proving the safety of every chemical in production and any new chemical seeking to enter the market.
Over the last several months, Sen. Lautenberg has chaired a series of hearings to help craft the “Safe Chemicals Act” with dozens of witnesses including business leaders, public officials, scientists, doctors, academics, and non-profit organizations. Through the hearings, public health groups, environmentalists, industry representatives and the EPA have expressed support for reforms to our nation’s toxic substance laws. The “Safe Chemicals Act of 2010” comports with the reform principles laid out by the Obama Administration, the American Chemistry Council and the Safer Chemicals Healthy Families Coalition.
The text of the "Safe Chemicals Act of 2010" can be found here and a full summary of the bill can be found here.

Highlights of the “Safe Chemicals Act of 2010”

Provides EPA with sufficient information to judge a chemical’s safety. Requires manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing. EPA will have full authority to request additional information needed to determine the safety of a chemical.
Prioritizes chemicals based on risk. Calls on the EPA to categorize chemicals based on risk, and focus resources on evaluating those most likely to cause harm.
Ensures safety threshold is met for all chemicals on the market. Places the burden of proof on chemical manufacturers to prove the safety of their chemicals. All uses must be identified and determined safe for the chemical to enter the market or continue to be used.
Takes fast action to address highest risk chemicals. Requires EPA to take fast action to reduce risk from chemicals that have already been proven dangerous. In addition, the EPA Administrator is given authority to act quickly if any chemical poses an imminent hazard.
Creates open access to reliable chemical information. Establishes a public database to catalog the information submitted by chemical manufacturers and the EPA’s safety determinations. The EPA will impose requirements to ensure the information collected is reliable.
Promotes innovation and development of green chemistry. Establishes grant programs and research centers to foster the development of safe chemical alternatives, and brings some new chemicals onto the market using an expedited review process.

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Posted by Blogmistress on April 16, 2010 in Ecological/Cultural Sustainability, Regulatory Issues, Safety/Toxicity | Permalink | Comments (2) | TrackBack

March 29, 2010

Rosewood & Guaiacwood oils Controlled Under CITES Appendix II.

by Tony Burfield. March 2010.

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

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

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

Posted by Tony Burfield on March 29, 2010 in Ecological/Cultural Sustainability, Essential Oils/Plant Extractions, Perfumery, Regulatory Issues | Permalink | Comments (0) | TrackBack