the aromaconnection blog

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.

Negative Bias

by Robert Tisserand

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

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

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

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

Coriandrum sativum

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

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

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

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

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

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

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

Data from Schnuch et al 2007

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

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

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

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

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

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

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

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

Allergies & immunotoxicity
Miscellaneous
Neurotoxicity
Data gaps

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 saying...in 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.

Notes & News

A new lemongrass variety “suwarna” has been developed by the Central Institute of Medicinal and Aromatic Plants to address drought conditions with a limited amount of planting material released in Uttar Pradesh.  This new variety will produce about 200 kg of oil per hectare as compared to normal varieties that produce about 100-124 kg per hectare. This is an attempt to diversify the income of farmers, particularly those in drought-affected areas.

The International Aloe Science Council presents a scientific primer on aloe. IASC has assembled a comprehensive document exploring the different varieties of aloe, their health properties, cultivation techniques and more. Download this e-book to learn about:

• commonly traded aloe species primarily used in the nutrition industry, and key components;
• cultivation considerations;
• aloe vera as a market commodity, including pricing information;
• a detailed appendix on aloe species; and
• details on requirements for organic certification.

The International Fragrance Association (IFRA) has appointed Aurore Boudet scientific and regulatory affairs manager. She will focus on the management and implementation of the IFRA code of practice, IFRA standards, and the compliance program.

The Research Institute for Fragrance Materials (RIFM) has formed an environmental adjunct group to support the expert panel’s efforts in environmental assessment of fragrance materials and development of IFRA Environmental Standard.  The group includes Michael McLachlan, professor of analytical environmental chemistry, Stockholm University, Sweden, and Beate Escher, deputy director of the national research centre for environmental toxicology, University of Queensland, Australia.  These appointments bring expertise in advising RIFM, especially  in the areas of environmental fate and bioaccumulation.

We at aromaconnection want to remind our community to support an outstanding nonprofit effort: United Aromatherapy Effort (UAE), headed up by Sylla Sheppard-Hanger, was founded in 2001 to support emergency and disaster relief workers by providing rejuvenating aromatherapy and massage services during long and arduous rescue efforts after 9-11.  The group continues to solicit aromatherapy supplies and monetary donations to provide support to U.S. troops in Afghanistan.  We urge you to visit the UAE website to learn how you can contribute.

Notes and News

Those involved in natural cosmetics and the manufacture of aromatherapy products  in the United States are not always aware of what’s percolating in regulatory circles across the pond.  There is a searchable database, COSING, established by the EU, which is extremely helpful to quickly find pertinent information.  These regs may or may not appear in our own rules here at home as the FDA continues to masticate on the globalization act of 2008.   Of the greatest interest, rules regarding the 26 fragrance allergens now required to be labeled on cosmetic packaging if in products above 10 ppm in leave-on products, or 100-ppm in wash-off products.  Perhaps 50% of these allergens are found naturally in limonene, citronellal and linalool . . . all which occur in essential oils.  In this directive, fragrance allergens are considered regardless if they come from essential oils or synthetic manufacture. 

We owe great thanks to Tony Burfield for his diligence over the past two years to provide information here on aromaconnection about EU directives, IFRA and other regulatory issues.

The volunteers at aromaconnection have all been very busy with other aspects of their lives for a bit of time, however, we hope to be back stronger than ever by the fall.      

Call for Support for Firefighters/Victims in Australia

United Aromatherapy Effort is helping to mobilize efforts and donations to help wildfire relief efforts throughout Australia.  Any supplies or monetary donations would be welcome.

AUSTRALIAN WILDFIRES
March 21, 2009 NEWS: CALL TO ACTION
Once again the amazing power of the internet, and all our interconnections have enabled us to network this call to Action (feel free to forward).
We are mobilizing to help out with the teams already working for the Wildfire Relief Effort. The Australian Practitioners Emergency Response Network (APERN) exists to help frontline emergency workers fulfill their duties in an emergency/critical incident and to support volunteers and victims in a caring and compassionate way. The blog: http://therapistsunite.blogspot.com/2009/03/apern-bulletin-tuesday-10th-march-2009.html. It emerged from the events of Black Saturday, the 8th February, 2009 when extensive bush fires in resulted in over 200 deaths. APERN is still in its formation stages and they are all volunteers. In addition Hands on Health Australia or HOHA http://www.handsonhealth.com.au/ aims to assist communities to improve the delivery of health and other services to marginalized people, utilizing the resource of community volunteers. They are looking at setting up 7 community clinics. At present some clinics are running and others are still in progress. Some communities around Whittlesea are only just returning to their homes to begin the rebuilding stage. There are 7000 people still homeless and living in tents, having survived one of the worst tragedies. (News links on the UAE site if you need a reminder.)
Supplies (respiratory blends, relaxation, clinic supplies like towels/base oils, etc) can be sent to Tuesday Browell ([email protected]) 424 High Street, Echuca, Victoria Australia. 3564 mobile ph is.0428342957.
In addition Ron Guba/Essential Therapeutics in Melbourne is collection donations for oil supplies if you want to purchase local supplies toward the Relief effort: visit http://www.essentialtherapeutics.com.au he will see your purchase is mixed into respiratory blends, or other useful products and delivered via the above organizations. Ultrasonic diffusers would be great for the seven clinics if someone wants to contribute those, contact Sheriar Irani in Sydney www.subtleenergies.com.au
This is a great quick way we can help rather than sending our own supplies.
Thank you in advance for any support as we mobilize globally to help out when we can. Please feel free to forward this to any other lists or organizations, and other caring aromatic friends.

Sylla Sheppard-Hanger
www.UnitedAromatherapy.org

Is This The End of The Indie Beauty Products Boom as We Know It?

The past decade has seen an explosion of small, independent aromatics products companies emerge from the kitchens and basements of America.  From aromatherapy wellness products creators, indie natural perfumers,  sultry incense  formulators,  handmade soap makers and makers of bath products galore - creative entrepreneurs have conjured up myriad offerings from bath fizzies to sugar scrubs to pampering spa products. 

Then, along came the Food and Drug Administration Globalization Act of 2008, announced last month, proposing to give the FDA authority to affect new regulations that could stop the growth of this creative movement dead in its tracks.  For some, it could be the end.  Under the new rules proposed, The FDA could mandate an annual registration fee of no less than $2,000 (possibly more) per manufacturing facility.  This could put some out of business.    

The Personal Care Products Council (formerly the Cosmetic, Toiletry and Fragrance Association), has already testified before the House Committee on Energy and Commerce, outlining the self-regulatory efforts of the major cosmetic industry over the past several decades.  From the written testimony of Pamela G. Bailey, CFO and President of the PCPC,   "The result of manufacturer safety practices and voluntary initiatives under a existing framework of Federal law has been an outstanding safety record that has been commended by previous FDA Commissioners.  Cosmetics and personal care products are the safest category of products regulated by the FDA."  Stephen F. Sundlof, D.V.M., Ph.D., Center for Food Safety and Applied Nutrition, also submitted testimony which included the following:  "We believe the proposed legislation should be more closely targeted and prioritized according to risk. Several of the legislative sections appear not to be sufficiently focused on high-risk products. Some of these requirements would divert resources, which could detract from important product safety and security priorities."   While these larger entities are not arguing for or against the proposed legislation, these seem to be cautionary statements that would lead us to believe the larger industry has faith in existing industry efforts to self-regulate cosmetic safety via the CIR (Cosmetic Ingredient Review) established by CFTA in 1976 and funded entirely by the industry, evaluating more than 1,300 ingredients and publishing peer-reviewed scientific literature, available to the public. 

We are fortunate to have Donnamaria Coles Johnson who because of her passion for cosmetics and beauty products has tirelessly championed for small beauty products companies.  If you are a small cosmetic manufacturer and are not a member of the Indie Beauty Network, you are missing a plethora of ideas, education and networking to assist your business development.  Donnamaria has put up a public page to address this latest FDA issue, open to the public for comments and suggestions.   She will be preparing a position paper, using members' comments that will carry our voice to be heard by the Committees in charge of vetting public comments.  You can find Donnamaria's message and governmental links here:  http://www.indiebusinessforum.com/forumdisplay.php?f=41 

We urge all small natural cosmetic manufacturers to keep abreast of this issue and join efforts as needed to make sure that indie business doesn't get left behind.     

Organic/Natural Standards to be Discussed at Upcoming Meeting

The big players in the Beauty Products World are gathering together in New York later this week at "The Natural Beauty Summit" to "create a forum to learn and discuss the key challenges the cosmetics industry faces in the areas of natural and organic products as well as sustainability" . . . or so says the program for the conference, to be held at the Hilton Hotel in New York City May 15-17. This is a followon to a similar summit in Paris last November, to be followed by a sequel, again in Paris, in October 2008.

Sponsored by Organic Monitor and Beyond Beauty Paris, the main focus of this conference will be Natural Cosmetics with a major session on Standard & Regulatory Issues followed by a panel discussion, and the next day a Natural Cosmetics Workshop focusing on "an assessment of the growing number of standards and certifications for natural and organic cosmetics . . . [with] a critical review of the major standards, comparing and contrasting the similarities and differences between them."

The list of standards and proposed standards that will be covered at the session is:

• A Retail products standard proposed by Whole Foods
• the USDA National Organic Program Standard applied to Cosmetics
• the American NSF Standard
• the OASIS Standard
• A review of European natural and organic standards harmonization
• ECOCERT and BDIH

The aromaconnection blog will be following these issues closely as they develop.  Notably missing from the above list is the NPA (Natural Products Association) standard we blogged about yesterday and last month. We are working on a table showing details of the standards and comparing their features.  In fact, we are probably duplicating what may show up in the proceedings of the NBS (if there are any), but we hope to get it into print sooner.

Organic Monitor, one of the co-sponsors of the NBS, predicts that 2008 will be the beginning of "an industry shake-up" as various standards are unveiled in Europe and North America. In this linked article, they reference several standards that are not included on the list above. They also express concern about fragmentation that could lead to a reduction of trade, but express also the "more optimistic view" that Cosmetics might follow the lead of the textile industry and develop a harmonized global standard.

In the meantime the infighting has already begun. OCA and Dr. Bronner's have challenged what they call "weak" ECOCERT and OASIS standards, according to this OCA Press Release widely reported in the media mid-March. And as we reported yesterday, the C.A.M. Report is somewhat skeptical of the whole idea.

We can probably look forward to an exciting year!

Technorati Tags: organic standards,natural standards,cosmetic standards,NSF,OASIS Standard,ECOCERT Standard,BDIH Standard

Perfume Politics: The Oppressive Perfumer's Guild

Guilds are perhaps the precursors of modern trade unions, and also, paradoxically, of some aspects of the modern corporation.  Guilds are actually small business associations and have little in common with trade unions.  They are more like cartels in that they assume exclusive privilege to produce certain goods or services or dictate standards of a profession.  Guilds can establish restrictive guidelines or a rigid system and can exclude those who do not abide.  Guilds emerged with a similar spirit and character to the original patent systems and are not generally conducive to a democratic free flow of development and interaction.   

In the modern democracy, we have created nonprofit organizations or NGO's intended to benefit a group by collective efforts and by providing public education or  services that benefit society.  Legal nonprofit corporations receive tax relief, but are required to provide public reporting and transparency.  Such nonprofit endeavors are usually governed democratically and operated by officials periodically elected from within the membership.  This creates a structure that will evolve the endeavor into the future separate from and not dependent on or owned by any one member. 

The French Perfumer's Guild of antiquity was perhaps the worst example of the power a Guild over its members.  Established by an edict of King Philippe-Auguste in 1190 (reconfirmed by patent letters by King Jean in 1357, again by King Henri III in 1582, and again by Louis XIV in 1658, the "confrerie des Maitres Gantiers et Parfumeurs") that primarily gave glovemakers of the extended medieval period the exclusive right (i.e., monopoly) to manufacture and sell cosmetics of all types.  Why glovemakers, you ask?  Gloves were made from leather tanned using urine and other toxic and putrid substances and needed to be scented before they could be respectably worn.  The glovemakers were wealthy manufacturing businesses and they were quite adept at organized efforts to lobby each respective monarchy, reminding of the importance of their role in medieval society and thereby acquiring the sanction necessary to maintain their monopoly.  And, one can also suspect that favors were extended.  Today, we might call them bribes.  As you can see, this monopoly continued for a long time and was grounded in the necessity for perfuming what would otherwise be unusable products - leather gloves.   The corporation or guild, headed up primarily by master glovemakers,  established the sole credentials of those who could sell gloves as well as perfumed goods and dictated the kinds of products they could manufacture . . . a long list including sachets with perfumed powders, compositions used in burners for environmental scent, pomades for the hair, soap, cosmetic creams, scented gloves and even tobacco.  A quaint novelty to us today, but in common use then, was the "oyselets de Chypre."  These were cloth birds in bright colors, decorated with feathers and stuffed with aromatic powders, then placed in ornate cages and hung from ceilings or walls to add fragrance to a room.

By 1750, there were 250 master perfumers, members of the corporation who had served 4 years as an apprentice and an additional 3 years as "compagnons" before reaching the status of master.  For all intents and purposes, they were slaves, not free (until the Revolution that is) to work outside the confines of the guild or to develop their own trade and commerce.  Only rarely were there exceptions, a notable one being René Le Florentin, Catherine de Medicis's personal and favorite perfumer.  Le Florentin had a reputation for talent in creating scents and fabricating poisons!  And, obviously Catherine was well positioned to demand for him premature status.

Everything changes.  Along  came the French Revolution, rendering perfume and other objects considered frivolous luxury symbols of excesses of the aristocracy out of favor.  With the exception of popular scents like, "parfum á la Guillotine".  Under the Terror, choice of scent indicated political affiliation, a kind of odorous password.  Politically correct scents could literally save one from execution.  Napoleon's return from conquering (so he claimed) Egypt, along with his renowned heroic status gave him the power to re-establish the importance of French manufacturing to the glory of the nation.  His fondness for cologne bode well for the lagging perfume industry, establishing imperial commissions as well as scientific and technological research in organic chemistry . . . a science that would revolutionize the perfume industry in the latter half of the 1700's.   Thus, the adjective "French" is aligned with the noun "civilization" and under a new empire, cosmetic luxury products had a more general and populist allure.

One would hope that we are beyond the oppressive restrictions imposed on the medieval creative perfume artists of the day and that individuality and inventiveness are the modern dictates for his or her endeavors and acceptance.  And, that perfume guilds are fashioned after the democratic principles of modern non-profits and NGO's. 

References

Stamelman, Richard, "Perfume: A Cultural History of Fragrance from 1750 to the Present", 2006, Rizzoli International Publications, Inc.

Classen, Constance, Howes, David, Synnott, Anthony, "Aroma: The Cultural History of Smell", 1994, Routledge Press

Newman, Cathy, "Perfume: The Art and Science of Scent",  1998 National Geographic Press

http://www.wikipedia.org/

Cropwatch at the Cross-Roads

Cropwatch Statement

After 4 or 5 years of continuous activity, Cropwatch has some choices to make. Do we go on the way that we have been, snapping at the ankles of those who run & regulate the aroma industry so badly, or should we 'old dogs' learn some new tricks? Cropwatch supporters, and organisations sympathetic to our aims, regularly offer us donations and advise us of potential sources of grants, to which we have always said 'no thanks, we're non-financed'. Our current thinking is that this might be a mistake, since we are limiting our potential effectiveness. .

We are certainly not asking everyone for money, but we are asking you to help us with some feedback on how a financial input could potentially help the aroma world to become a better & fairer place, so please mail us if you have any thoughts or ideas.

Our initial list of ideas to use donated funding would be:

1. To finance risk/benefit studies on natural aromatic products. This research is needed because the existing major players such as IFRA/RIFM, are set up only to investigate the risks/hazards of fragrance ingredients (but not the benefits), & EFFA can only present the safety risks of essential oils, absolutes, resinoids etc in terms of the imagined hazards of the individual contained chemicals, rather than adopting a holistic approach for the aromatic ingredient as a whole. Therefore both organisations are badly positioned to defend natural aromatic ingredients against the current avalanche of restrictive legislation. The EU Commissioners have previously declined to accept safety-data based on risk/benefit considerations, although we believe this policy to be untenable in the long-term - it is the norm in virtually every other regulatory area (biocides, agricultural chemicals, pharmaceuticals etc).

[Neither is this just a European problem. The U.S. House Committee on Energy and Commerce have just announced draft legislation (Global Harmonisation Act 2008) intended to stimulate discussion on how to provide adequate funding and authority for the FDA to ensure the safety of the nation's food, drug, medical device and cosmetic supply in an increasingly globalised marketplace. The draft legislation already highlights several areas which will affect the fragrance industry]. 

2. To develop statistical data on the adverse effects of restricted & prohibited aromatic materials. This data would be a potential bombshell to blow apart the over-precautionary approaches of the cosmetic regulators and career toxicologists, who are in such a powerful position in global regulatory circles. Where this data exists (e.g. the Schnuch data on alleged allergens) it is already causing red faces. The EU Commissioner has previously indicated to Cropwatch (Brussels 2007) that this type of adverse reaction data is inadmissible as safety evidence. But if you are familiar with English history, you might recall that King Canute failed to hold back the waves and so his followers realised he was not all-powerful. So too, the regulators will not be able to ignore the fact that many restrictions on natural products are based on corporate toxicological constructs which don't manifest in the great numbers of negative health effects predicted.

3. To assist with the growing & production of useful commodities from threatened aromatic plants, for cosmetic, aromatherapeutic, flavour & medicinal outlets, in a way that benefits the poor.

4. To set up or help set up a natural aromatics products professional body, with the help of other interested parties. Already we can identify several sub-divided areas which badly need assistance: natural perfumery, the use of naturals within conventional perfumery, natural biocides, herbal drugs & medicines, aromatherapy, natural cosmetics etc. 

5. The lobbying of officials & regulators. As we have seen, the more the establishment closes ranks (and its mind) to contrary & dissenting views, the more popular support we have been able to attract. In terms of numbers we are potentially a powerful force. However we have to ask ourselves whether there is any point in continuing the lobbying game. Many of the points we make go unanswered because the officials involved are not sufficiently technically adept or experienced to even understand the arguments put forward. So is it better to plough ahead with a voluntary regulatory system of our own making - at least we might have the experience, familiarity & resources to do a better job. The enormity of the task is detracting, but this is put more into perspective if sufficient funding were to be available.  

6. To keep the flame of our traditional perfumery heritage alight. When we read that several major aroma corporations are training fledgling perfumers in pure synthetic perfumery, it makes us wonder if the world has gone quite mad. Once perfumers used to be creative artists with forthright temperaments, views and opinions, passionate about their art. Now, are we all to be reduced to company drones? I was related a story recently concerning a certain essential oils salesman who offered unmarked samples of  real good quality Bulgarian lavender oil, and a synthetic lavender construct to a group of young perfumers at a certain megacorporation. The group preferred the artificial lavender construct because "it smelled like linalyl acetate, like its supposed to."  Heaven help us! But maybe some of us 'old-timers' should organise courses & lectures to pass on the 'ancient knowledge of the art of perfumery' before it is lost forever.   

OK, after 5 or so years of trying, we pretty much know what the problems facing us are - what we don't have is a consensus on the best way to solve them. Maybe you can help?

Cropwatch Team

Technorati Tags: Cropwatch,natural aromatic products,perfumery,natural perfumery