the aromaconnection blog

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

IFRA 2009 Standards, including amendments as of October 14^th 2009. International Fragrance Association, Brussels. http://www.ifraorg.org

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 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.

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.

The Safe Cosmetics Act 2010

by Robert Tisserand

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

References

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Tunnel vision

by Robert Tisserand
Reprinted with permission

People should expect reasonable and sensible protection from harm by those who regulate consumer products, and vulnerable groups such as children and pregnant women may need special consideration. Therefore, cosmetics that are totally free of all carcinogens and teratogens may sound like a good idea. But is it realistic? And is more legislation needed?

One problem is in that word “totally”. If you want to avoid encountering one molecule of a toxic substance, then you need to either live in a bubble, or stop eating, drinking, and breathing. Traces of cyanide, for instance, are found in foods and beverages, both natural and manufactured. That doesn’t mean its OK to consume in quantity, but toxicity is avoided by limiting the permitted amount to a few parts per million. The same goes for heavy metals and in fact most other toxins.

Why not zero tolerance? Well, in many cases it is both unrealistic, and unnecessary. All toxic substances have NOAELs (No-Adverse-Effect-Levels) even carcinogens. NOAELs are established in animal studies, and then ratcheted down by 100 or 500 or 1,000 times. These mathematical excursions are a bit arbitrary sometimes, but if anything, they result in too much protection, not too little.

A “zero tolerance” bill is on the table in the state of Colorado, and you can find more information about it here and here. Enacting this bill would mean, for example, that any amount of acetaldehyde would not be permitted in personal care products. Your body produces acetaldehyde whenever you drink alcohol, as it’s the major metabolite of ethanol. And chronic alcoholism can lead to cancer, with acetaldehyde the main suspect. Acetaldehyde is also a trace constituent of apples, bananas, bilberries, cherries, citrus fruits, cranberries, grapes, olives, passionfruit, peaches, plums, strawberries, raspberries, carrots, celery, cucumbers, garlic, onions, peas, potatoes and tomatoes. So, goodbye fruit extracts in cosmetics.

If you see a strawberry only as something that contains acetaldehyde (tunnel vision), then suddenly, everything you thought was good for you, is now bad for you. But (problem number two), fruits and vegetables contain a plethora of antioxidants and antimutagens that more than compensate for any toxicity from the tiny traces of acetaldehyde they contain.

Also, goodbye to rose otto and rose absolute. It was nice knowing you. And so long to nutmeg oil, mace oil, myrtle oil, basil oil, holy basil oil, citronella oil, ho leaf oil (linalool ct), elemi oil, and many other less common essential oils. Not because they contain acetaldehyde, but because they contain methyleugenol (ME). ME is occasionally found in traces in rosemary oil, clove oil, hyssop oil, tea tree oil, cananga oil, mastic oil, cassia oil, cinnamon leaf oil, savory oil, black pepper oil and, again, many others. Have you eaten any fresh basil or pesto lately? Then you have been consuming ME. But, neither fresh basil nor pesto is carcinogenic, because they also contain antimutagens and anticarcinogens that counteract any toxic effect of ME. I’m not just saying this, it has been demonstrated. The same goes for holy basil oil, to take one example – not only is it non-carcinogenic, but it is actually anticarcinogenic. The high content of geraniol in rose otto is almost certainly protective because of its anticarcinogenic action.

Does this make a difference? Not if you have tunnel vision.

The Environmental Working Group (and associated Skin Deep and Campaign for Safe Cosmetics) is an increasingly vociferous pressure group, which is now flexing its political muscle. Everywhere these people look, they find dangerous toxins, and guess what – if you look for them you will find them. And, if your vision becomes so narrow that all you can see is toxins, and the poor fetuses and children that you convince yourself they must be harming, it becomes difficult to take a step back and see the big picture. The EWG do not seem to appreciate that finding a substance in human tissue does not necessarily mean that the owner of that tissue has been harmed.

Risk assessment has many facets (problem number three) but basically it is about deciding whether exposure to a substance in a particular way is or is not actually harmful, and where safety thresholds lie. Risk assessment is not about scaremongering, it’s not about getting people fired up about “chemicals”, and it should not be about pre-emptive and sweeping legislation. It should be about ensuring safety by looking at all aspects of a problem, and then making the best decision you can. I agree with many of the EWG campaigns. It’s just a shame that they have adopted the same “single-chemical” view of essential oils that has infected the EC legislation.

If you live in Colorado and you agree with my opinion, you should act. If you don’t live in Colorado stay vigilant, because there’s more of the same on the way.

Robert Tisserand is an esteemed aromatherapy educator, author, founder of the Tisserand Institute and consultant to the personal care products industry.

Colorado Safe Personal Care Products Act : Take Action Immediately

by Kayla Fioravanti
Reprinted with permission

If you live in Colorado or sell cosmetics into Colorado it is time for you to speak up.  Colorado has a proposed a bill before them during this session known as The Colorado Safe Personal Products Act.  This Act is so broad and vague that if it passes in this form the personal care shelves in stores would go bare.  You can read the entire bill here.  To follow the bill as it is updated click here and change the range to House Bills 1201-1250 and then scan down to 1248.   

As of February 3, 2010 the bill was assigned to House Judiciary Committee. There is a hearing scheduled March 1, 2010 for sponsors and those opposing the act to be heard.  The committee meets in room 0107 (in the basement of the Capitol) beginning at 1:30 pm.

You can find the phone number and email addresses of your Colorado State Representative here.  The bill is sponsored in the house by Dianne Primavera phone # 303-866-4667 click here to email, Dennis Apuan phone # 303-866-3069 click here to email, Karen Middleton phone # 303-866-3911 click here to email, Joe Miklosi Cap phone # 303-866-2910 click here to email. 

The Women's Lobby of Colorado is holding open meetings.  They support this bill and even have the Campaign for Safe Cosmetics logo on their website.  Sadly, they have fallen for the bad science that the Campaign for Safe Cosmetics is using to cause hysteria.  The voices of small businesses in the personal care industry need to be heard.  The Women's Lobby of Colorado meetings are held at Colorado Education Association on the corner of Colfax and Grant—1500 Grant St—from 12:00-1:15 pm in the Bluebell Room. You can park free in their lot if you sign in in the lobby. Lunch will be provided. Upcoming meetings will be held March 3, March 17, March 31, February 3, April 14 and April 28. 

I will go into the faults of this bill in greater depth within the next few days, but in the mean time let me point out some of the serious flaws of this bill. 

"The bill creates the "Colorado Safe Personal Care Products Act" (act), which prohibits a manufacturer from knowingly selling, offering for sale, or distributing for sale or use in Colorado on and after September 1, 2011, any personal care product that contains a chemical identified as causing cancer or reproductive toxicity."  HOUSE BILL 10-1248

Quick Response:  Will these chemicals be ones that cause cancer when topically applied at normal usage percentges or will this information come from studies in which rats were injected with 100% concentration of said ingredients?  There is a big difference between putting an diluated ingredient on the skin than injecting an ingredient into the body at full concentration. 

"THE GENERAL ASSEMBLY (23) DECLARES IT TO BE IN THE BEST INTEREST OF THE PEOPLE OF THIS STATE (24) TO TAKE STEPS TO ENSURE THAT PERSONAL CARE PRODUCTS SOLD AND (25) USED IN THIS STATE ARE SAFE AND DO NOT CONTAIN SUBSTANCES THAT (26) CAUSE CANCER OR REPRODUCTIVE TOXICITY."  HOUSE BILL 10-1248

Quick Response:  There should be acceptable limits set and not a complete ban on ingredients.  Many things in nature in high doses are known to cause cancer; for instance the sun! 

"2 (1) "AUTHORITATIVE BODY" MEANS THE FOLLOWING AGENCIES OR (3) FORMALLY ORGANIZED PROGRAMS OR GROUPS RECOGNIZED AS (4) AUTHORITATIVE FOR PURPOSES OF IDENTIFYING CHEMICALS THAT CAUSE (5) CANCER OR REPRODUCTIVE TOXICITY:

6 (a) THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, (7) OR ITS SUCCESSOR AGENCY;

(8) (b) THE UNITED STATES FOOD AND DRUG ADMINISTRATION, OR ITS (9) SUCCESSOR ENTITY;

10 (c) THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND (11) HEALTH, OR ITS SUCCESSOR ENTITY;

12 (d) THE NATIONAL TOXICOLOGY PROGRAM, OR ITS SUCCESSOR 13 PROGRAM; AND

14 (e) THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, OR (15) ITS SUCCESSOR AGENCY." HOUSE BILL 10-1248

Quick Response:  I think this portion of the bill gets to the heart of the Environmental Working Group (EWG), aka Skin Deep, aka Campaign for Safe Cosmetics entire agenda.  The EWG wants to be that "or successor agency" mentioned in in the above list, my guess is the United States Food and Drug Administration (FDA).  The Cosmetic Ingredient Review Expert Panel is not listed as a resource for information on cosmetic ingredient safety.  Having any open ended "or successor agency" declare what causes cancer and what doesn't is dangerous. 

The EPA is an interesting choice as an expert on cosmetics.  I read over there list of cancer causing chemicals and only a very small handful are used in cosmetics at all.  I will give further detail on this list and provide a link to it this week. 

"5 25-5-1204. Prohibition - sale of personal care products (6) containing unsafe chemicals. ON OR AFTER SEPTEMBER 1, 2011, A (7) MANUFACTURER SHALL NOT SELL, OFFER FOR SALE, DISTRIBUTE FOR SALE, (8) OR DISTRIBUTE FOR USE IN THIS STATE ANY PERSONAL CARE PRODUCT (9) THAT CONTAINS A CHEMICAL IDENTIFIED AS CAUSING CANCER OR (10) REPRODUCTIVE TOXICITY. (11) 25-5-1205. Enforcement by private citizens - civil penalty. (12) (1) ANY PERSON ALLEGING A VIOLATION OF SECTION 25-5-1204 MAY (13) BRING AN ACTION AGAINST THE MANUFACTURER IN A COURT OF (14) COMPETENT JURISDICTION IN THE COUNTY WHERE THE VIOLATION (15) OCCURRED. UPON FINDING A VIOLATION, IN ADDITION TO ANY OTHER (16) RELIEF AUTHORIZED BY LAW, THE COURT SHALL ORDER THE (17) MANUFACTURER TO CEASE AND DESIST CONDUCT VIOLATING SECTION (18) 25-5-1204 AND SHALL ORDER THE MANUFACTURER TO PAY THE (19) PREVAILING PARTY REASONABLE ATTORNEY FEES AND COSTS.

20 (2) A MANUFACTURER THAT VIOLATES SECTION 25-5-1204 IS (21) SUBJECT TO A CIVIL PENALTY OF UP TO FIVE THOUSAND DOLLARS PER (22) VIOLATION PER PRODUCT FOR A FIRST OFFENSE, AND UP TO TEN THOUSAND (23) DOLLARS PER VIOLATION PER PRODUCT FOR A SECOND OR SUBSEQUENT (24) OFFENSE. PENALTIES COLLECTED PURSUANT TO THIS SECTION SHALL BE (25) DEPOSITED IN THE GENERAL FUND." HOUSE BILL 10-1248

Quick Response: Translation, the State of Colorado cannot afford to enforce this insane bill so they are leaving it in the hands of citizens to sue cosmetic companies.  After California passed California Proposition 65 there was wide spread abuse.  The lawyers got rich in California and companies wasted countless man hours and dollars defending themselves from all these lawsuits. 

This bill does not address "naturally occurring" substances found in natural ingredients.  For instance, lead would be banned, but lead is in water and cosmetics contain water.  The issue is severely complicated with naturally occurring substances since there is a complete ban and not tolerable levels.

A great example of by-product of some cosmetics is formaldehyde. In 1987, the U.S. Environmental Protection Agency (EPA) classified formaldehyde as a probable human carcinogen under conditions of unusually high or prolonged exposure.  In cosmetics there is not an unusually high or prolonged exposure to formaldehyde.  tissues. Formaldehyde is water soluble and is not stored in fat so it can be metabolized very quickly with a half life in the human body of about 1.5 minutes.

For a list of formaldehyde preservatives read here.  Formaldehyde is naturally produced our bodies, the air that we breathe, and even the food we eat.  Formaldehyde is emitted as a natural by-product in the cooking of certain vegetables like, Brussels sprouts and cabbage.

How many small companies could afford to do business in Colorado if this bill passes as it is written today?  Would you risk being fined $5000 or $10,000 when citizen take up bounty hunting cosmetic products for the promised cash reward?  If you were completely innocent could you afford to defend yourself from these potential lawsuits?