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.

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

Copyright © Tony Burfield June 2010

Preamble

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

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

The ‘Not So Sexy’ CSC Report

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

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

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

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

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

In the “what you can do” summary section of a review of the CSC report on the CSC website at http://safecosmetics.org/article.php?id=644 you are be urged to lobby to “pass laws that shift the entire industry to non-toxic ingredients and safer production.” Since most/practically all natural products now carry some sort of (so-called) hazard labelling or risk phrasing, this effectively means shifting to the world of “safe” synthetics. Since the EU Cosmetics Commission is also dedicated to the establishment of a synthetic world which is safer than nature (Burfield 2010), so perhaps they would both like to lock themselves permanently away in it? Just leave the real world to us non-paranoid inhabitants please, so we can enjoy it in all its alarming chemical dangers – alcoholic drinks, herbs & spices, pesto, trees, flowers and, err, … fragrance!

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

In Conclusion

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

References

Burfield T, (2010) – see Slide 14 at http://www.cropwatch.org/Tony Burfield at Cannes 2010.ppt

CSC (2010) – see http://safecosmetics.org/article.php?id=644

FMA (2010) “U.S. Fragrance Association Finds New Cosmetics Report Misleading – Fragrance Safety Is No Secret” May 13th 2010 http://fmafragrance.org/sub_pages/CSC_release2.pdf

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

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

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

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

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

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

 

Technorati Tags: Not So Sexy - The Health Risks of Secret Chemicals in Fragrance,fragrance,natural perfumery,perfumery,perfume

“Safe Chemicals Act of 2010”

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

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

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

Press Release of Senator Lautenberg

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

Measure Will Require Safety Testing for Chemicals

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

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

Highlights of the “Safe Chemicals Act of 2010”

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

# # #

Santolina Oil: banned IFRA, for no particular reason?

by Tony Burfield March 2010.

Matthias Vey had the decency to admit, at the BSP Safety Symposium on March 11^th at Cambridge UK, that IFRA’s banning of melissa oil in its 44^th Amendment was a mistake, albeit one made by his predecessor. Cropwatch considers that the fact that the mistaken ban was queried by humble perfumery technicians throughout the trade, but had apparently escaped the attention of RIFM’s Expert Panel, is an internal matter for IFRA to reflect about. Apologies from Vey too over the dithering with regard to the restriction, or should we say the suspended restriction, of vanillin in IFRA’s 44^th Amendment (previously queried by Cropwatch in Cropwatch Newsletter 15), and Vey explained part of the story behind the restriction of oakmoss qualities (first published by Cropwatch in 2008). If, from all this, you get the impression that perfume ingredient regulation is more a matter of politics than of robust scientific evidence, then you would be entirely correct

IFRA have also previously made clear their intentions to ban other essential oils. Santolina oil CAS 84961-58-0 (the botanical species not identified in the IFRA Standard), was banned on undisclosed grounds following an initial review under IFRA’s 40^th Amendment 2006. A survey of the IFRA membership had indicated non-support for its continued use. As you will all be aware, IFRA are very fond of saying they represent the industry, when they only represent a part of it, especially that part represented by the large aroma corporates. The fact that santolina oil has a moderate level of use in the trade (300 t/y in 1996) and finds applications in cosmetics because of its beneficial properties, appear to have been escaped the IFRA high-command.

Cropwatch has established a detailed monograph on santolina essential oil from Santolina chamaecyparissus L. (Cotton lavender) at http://www.cropwatch.org/Santolina chamaecyparissus L.pdf which contains references to as much published material as we can currently find. It appears that the composition of Spanish santolina oils from Santolina chamaecyparissus L. vary considerably according to the area in which they are grown, and which subspecies is used to prepare the essential oil (Pérez-Alonso & Velasco-Negueruela 1992). Published pharmacological investigations of S. chamaecyparissus extracts, and Information on Santolina oil so far declared in the IFRA-IOFI labelling manual 2009 (botanical information not indicated) do not indicate any grounds whatsoever for a complete ban of the ingredient for perfumery use.

This makes the reasons behind the IFRA ban of santolina oil all the more obscure. Information displayed on the IFRA site indicates that the RIFM Expert Panel gave three possible reasons, but, in true Kafka-esque fashion, we are not allowed to know which of them applies:

1. The presence of structural alerts as defined in the Human Health Criteria Document (Ford et al., 2000), and/or
2) Adverse data on the material itself and/or
3) Adverse data for a structurally related material

So are we in another melissa oil situation, where the reason for the IFRA ban suddenly evaporates when the evidence is revealed by a third party? We need to know because materials contained in santolina oil may occur in other natural aromatic products. And we need to know because banning an ingredient for undisclosed reasons smacks of toxicological imperialism.

References.:

Ford et al. (2000) “Human Health Criteria Document.” Reg. Tox & Pharm. 31, 166-181, 2000.

Pérez-Alonso & Velasco-Negueruela (1992) « "Essential oil components of Santolina chamaecyparissus L." Flav. & Frag. J. 7, 37-42.

Technorati Tags: santolina oil,CAS 84961-58-0,Santolina chamaecyparissus,IFRA

Powerpoint Text: Is excessive regulation destroying the perfumery art?

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

by Tony Burfield Cropwatch  www.cropwatch.org

Safety Issues in the Aroma Business.

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

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

 

The ‘Zero Risk Mindset’.

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

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

So How Dangerous is it to go Outside…?

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

Nature: Presents More Hazards than Using Fragranced Products?

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

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

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

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

 

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

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

REACH.

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

The Basis of REACH challenged

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

The importance of natural aromatic ingredients.

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

A Timid Industry.

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

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

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

A Lack of Cross-Disciplinary Expertise..

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

..and a Lack of Ecological Awareness..

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

Media Bad Science on Naturals – an Example.

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

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

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

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

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

Destroying the very foundations of perfumery.

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

Public Objections to ‘Safe’ Reformulations of Classic Perfumes.

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

Natural Ingredient Usage Declines.

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

The ‘Weak Animal Carcinogens’ Issue.

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

Some Inconvenient Classifications.

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

Legislation-Compliant Ingredients?

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

‘Allergic’ Fragrance Ingredients.

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

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

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

The Tea Tree Oil (TTO) Debacle

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

Vanillin

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

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

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

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

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

Coumarin

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

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

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

Other Fragrance Ingredients with Questionable Restrictions.

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

References.

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

Acronyms.

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

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

Technorati Tags: perfumery,natural perfumery,perfume ingredient safety,perfume ingredient regulation

Is excessive regulation destroying the perfumery art?

I (Tony Burfield) gave a talk entitled “Is excessive regulation destroying the perfumery art?” at the British Society of Perfumers Safety Symposium, 11th March 2010, held at the Belfry Hotel near Cambridge, UK; a Power Point version of the talk can be downloaded at http://www.cropwatch.org/Tony Burfield's talk to BPS final.ppt ). In contrast to the other speakers, who mainly advised on how to conform to the minutiae of existing REACH requirements, the new Classification, Labeling & Packaging (CLP) of substances & mixtures regulations, and other EU measures (as well as adherence to the IFRA CoP), I attempted to outline the disproportionate nature of EU Cosmetics legislation, and its attempts to create an artificial world of synthetic based products which would be safer than nature itself. I asked why the aroma industry had been so timid in the face of the burgeoning legislation which would all but destroy it, and why it couldn't find the time to challenge much of the bad science behind some of the more over-precautionary measures.

In a previous feature "Perfumers and the 40th IFRA Amendment" (Burfield 2007) first put out on Basenotes in Feb 2007, I had noted the declining importance & influence of the Professional Perfumer, no longer the courageous and opinionated artists, and rarely seen any more as company board members. Their decline in industrial status, often to a level slightly under that of the Regulatory Affairs Assistant, is even more evident now that previously. Yet I was informed one by a well-known perfumer working for one of the major fragrance corporates, that the new generation of software-using perfumers have no problem in conforming to the avalanche of new regulations. I interpret this as referring to a younger generation who have probably never smelled a genuine ylang-ylang oil, or an unadulterated sandalwood oil East Indian (as they are invariably ‘extended’ at source), and have a sparse knowledge or experience of the massive range of exotic natural aromatic materials. I further contend that they may well spend most of their working time tinkering with formulae, working on substitutions for contra-indicated ingredients such as cyclamen aldehyde, lyral, lilial or polycyclic musks, or lately even key materials like linalol (current shortage of this important ingredient apparently due to fire in a major producing facility in China).

Where do we go from here? With the impact of REACH set to remove a huge number of ingredients (both synthetic and natural) from the perfumers palette, and with over-exploitation continuing to endanger the future availability many natural aromatic materials, it is hard to see much future for the perfumery art in Europe, unless marketeering hype can induce consumers to buy products only suitable for consumers with unsophisticated tastes & perceptions. As previously mentioned, many consumers are noticing the increasing evidence of 'chemical' notes creeping into fragrances, and some have used fairly negative odour descriptors to Cropwatch about individual perfumes (out of the multitude of today's short-lived fragrance launches) which they perceive as smelling like 'cough candy', 'fly spray' or 'drain-cleaner'. I contend that the time is right for the centre of creativity, and progress in the art-of-the possible in fragrance design to move away from the West with its over-cautious ingredient restrictions. The toxicologists, who now seem to call the shots in this profession, have helped ruin the aroma industry, yet can only point to a vanishingly small number of instances where any alleged adverse consumer effects from fragrances have manifested as clear cut clinical cases. The future of perfumery surely lies outside the West, in countries which have more proportionate and should we say, a less hysterical approach to cosmetics health & safety regulation.

Tony Burfield
for Cropwatch.

Technorati Tags: perfumery,natural perfumery,IFRA,REACH,BPS,British Society of Perfumers

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?

Notes & News

The authors at aromaconnection have been otherwise occupied and we apologize that it’s been rather silent here of late.  We’ll be placing some major reprints of interest in the next few days.  In the meantime, here are a couple of items in the news.

According to Cosmeticsdesign.com, the EPA has issued the first of its Chemical Action Plans (CAPs) that appear to strengthen the agency’s authority regarding laws that protect Americans from exposure to harmful chemicals.  With this move, the EPA appears to have a new focus on phthalates and is, of course, challenged by the American Chemistry Council (ACC).  The complete EPA Phthalates Action Plan can be read here. In addition to being used as a chemical ingredient to soften vinyl plastics, Diethyl phthalates (DEP) are used as a dispersing agent for reed diffusers, a popular method of adding fragrance to the household environment. Most natural products companies avoid use of DEP and you will find cautions for its use from aromatherapy companies who choose to not use synthetic chemicals.   The EPA has previously established the Endocrine Disruptor Screening Program beginning in 2009, with the Notice of Tier 1 Screening of the first 67 chemicals to be evaluated (order issuance for Diethyl phthalate Jan 2010).  We will be watching the evaluations and update EPA resolutions as they come about.

Robert Tisserand has launched a new website which includes his I’m Just Saying blog which is a welcome new addition to internet discussions surrounding aromatherapy and the use of essential oils.