the aromaconnection blog

Ingredient obsession

by Robert Tisserand

I am not against transparency in labeling. I think it’s a subject that could use a lot of discussion. But I am against ingredient obsession. In a society that allows alcohol, tobacco and firearms to be freely purchased, and that turns a blind eye to the widespread use of illegal drugs, why are we concerned about whether a consumer product might contain a few parts per million of chemical X? Should we not be concerned, rather about whether the product itself is safe?

Ingredient tunnel vision is seriously bad for your health. It will turn you into an obsessive, paranoid, vicious, spitting fireball of righteous indignation. You will write searing blog posts, develop gastritis or worse, lose sleep, and die young. And for what? Essential oils and their constituent chemicals are very frequent targets. Because essential oils contain chemicals, and because almost all chemicals are, to some people, toxic by definition, many bloggers in the green movement have become anti-fragrance and anti-essential oils. For a while I though that, when they realize that linalool is found in lavender oil, and that limonene is in lemon oil, they will relent. I was wrong. Obsession is, in fact, relent-less. It allows no release, no vacation, no light side. It is all-consuming!

Because essential oils are alleged to contain “allergens”, they are also favorite targets of regulators and legislators, especially in Europe. And, we in North America know full well that whatever happens in Europe must be good, because Europeans are more intelligent. Their accents prove this. Since I have been living in the US (12 years now) my accent has slowly become less English English, and more American English, and my mental faculitoes have detturiated protortionisely, as you kan see.

Peer-not
More on Europe soon. But first, a new study financed by Silent Spring Institute, written by Robin Dodson et al, and published in Environmental Health Perspectives. EHP claims to be peer-reviewed, but if this report is anything to go by, its reviewers need replacing. In fact, they might as well not bother with peering, since it clearly accomplished nothing. The report is entitled: Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products. Classes of chemicals that were tested for include UV filters, cyclosiloxanes, glycol ethers, parabens, phthalates, alkylphenols and fragrances. The “fragrances” tested for include these essential oil constituents:

For your edification, I have highlighted one essential oil and also some foods that naturally contain said chemical. No rationale is given for why these particular substances were selected. This is important, not only because they have now become what might be called “target chemicals of concern”, but because the list could have been so much longer. It could include almost every essential oil constituent in existence. Now, at a rough guess, this is in the region of 1,000. The above list is said to represent “asthma-related chemicals”. This is not defined anywhere, but the article begins with “Laboratory and human studies raise concerns about endocrine disruption and asthma from exposure to chemicals in consumer products” and it goes on to talk about “asthma-related chemicals.”

Fragrance chemicals do not cause asthma, but they can exacerbate asthmatic symptoms. Many fragrance chemicals have this potential because they are very mild respiratory irritants in concentration. It’s the nature of the beast. However, listing limonene, isobornyl acetate, terpineol etc., is not helpful. If you are asthmatic, and you tend to react badly to fragrances, then you stay away from fragrances. Mounting a new campaign to list particular fragrance ingredients on consumer labels will not accomplish anything. It will not meaningfully make fragrances safer, and if consumers need a warning that a product is fragranced, this can be accomplished in either one word: “FRAGRANCE”. Or two: “CONTAINS FRAGRANCE”.

The paper states that, if a compound is “available from plant materials”, it was described as natural, and if “commonly synthesized”, then it was described as synthetic. But there is no list! No classification! So we don’t know which they regard as natural, and which as synthetic! In the text, limonene is mentioned as being natural (correct), isobornyl acetate as synthetic (incorrect) and hexyl cinnamaldehyde as natural (incorrect, since it is always synthesized. It is also spelled wrongly throughout the article. I’m Just saying…).

No direct evidence is provided for any adverse health effects for any of these compounds, and there is no discussion of the factors involved, although several papers are cited: “Fragrances, particularly terpenes such as limonene, are associated with secondary chemical reactions in indoor air, and can contribute to the production of formaldehyde, glycol ethers, ultrafine particles, and secondary organic aerosols (Nazaroff and Weschler 2004; Singer et al. 2006). Exposure to fragrances has been associated with a range of health effects, including allergic contact dermatitis, asthma and asthmatic exacerbations, headaches, and mucosal symptoms (Heydorn et al. 2003; Kumar et al. 1995; Steinemann 2009).”

Dodson and friends do not mention that moderate-to-high levels of ozone are required for these reactions to take place, nor that cleaning products (which can also contain volatiles such as formaldehyde, benzene, toluene and xylene) are the only ones that have been reported to cause actual health problems (Nazaroff and Weschler 2004). Ozone-limonene reactions can produce hydroxyl radicals, and these in turn can contribute to formaldehyde formation (Fan et al 2003). However, this was only observed under conditions that were admitted to be not typical of “nonindustrial indoor environments.” And, the statement that terpenes such as limonene can contribute to the formation of glycol ethers is not true. Nazaroff and Weschler (2004) state that both terpenes and glycol ethers were found in some cleaning products, not that one is formed from the other! And while I’m on my soapbox,, ultrafine particles and secondary organic aerosols are the same thing. Now, if I can find this many holes in a research paper without breaking a sweat, where is the so-called “peer-review”? And how much credence can we give any of the findings?

The Kumar et al (1995) study did find exacerbation of respiratory symptoms in asthma patients when they smelled perfume scent strips, as used in magazine advertising. And other research shows that if you give asthma patients strong fragrances to inhale, they may react adversely. The same is true for people with multiple chemical sensitivity, but it is not true of the general population.

Under extreme conditions terpenes such as limonene and pinene do form particles that are respiratory irritants. These conditions require (a) moderate-to-high ozone, and (b) substantial quantities of vaporized terpenes. These may be hazardous for vulnerable individuals, such as babies, older people, or people with asthma. However, it’s a leap to assume that fragrances cause health problems. They don’t. Yes, a fragrance could trigger an asthma attack in a person with asthma. But it cannot cause asthma. In a mostly supportive Forbes blog post based on Dodson’s article, Amy Westervelt quotes the following lines:

“This study presents a clear example of biased, advocacy-based research,” says William Troy, Ph.D., Scientific Advisor the International Fragrance Association North America. “It is a repackaging of older information and the methodology used defies basic principles and standards of scientific protocols and investigations. The advice to consumers based on study findings is simply wrong,” said Dr. Troy.

“There’s been a lot of work done on exposure to these chemicals in average households, and we know that these chemicals are found in air and dust in peoples’ homes, and the CDC [Center for Disease Control] has shown that we find them in our bodies as well,” says the study’s lead author Dr. Robin Dodson. “Now we’re trying to understand where the chemicals are coming from, and how people are exposed to them.”

There is a degree of naivete in this last statement. As far as the fragrant compounds are concerned, they are naturally found in some common foods (see Table), so that could be one reason that they are found in our bodies. Limonene and pinene are ubiquitous simply because so many trees produce them. If you have pine furniture, it is giving off limonene and pinene vapors. If you have paint thinned with turpentine, same deal, because turpentine is made from pine trees. If you live near trees…basically, if you’re breathing, you are inhaling limonene and pinene. How much you are inhaling, what the ambient ozone level is, and whether or not you have asthma are all considerations in whether these vapors might present a hazard. Some advice:

• If you are asthmatic, beware of strong fragrances.
• In high-ozone conditions (usually hot weather combined with factory exhalations and/or much vehicular traffic) beware of exposure to high levels of fragrant molecules.
• When using cleaning products, paints, glues or varnishes, ventilation is important.
• Note that some types of office equipment, such as photocopiers and fax machines, give off ozone.

Dodson advises avoiding fragranced products, and looking for ones with plant-based ingredients. So would that include or exclude essential oils? I’m baffled.

References
Dodson R, Nishioka M, Standley LJ et al 2012 Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products.

Fan Z, Lioy P, Weschler C et al 2003 Ozone-initiated reactions with mixtures of volatile organic compounds under simulated indoor conditions. Environmental Science & Technology 37:1811-1821

Heydorn S, Johansen JD, Andersen KE et al. 2003 Fragrance allergy in patients with hand eczema – a clinical study. Contact Dermatitis 48:317-323

Kumar P, Caradonna-Graham VM, Gupta S et al 1995 Inhalation challenge effects of perfume scent strips in patients with asthma. Annals of Allergy Asthma & Immunology 75:429-433

Nazaroff WW, Weschler CJ 2004 Cleaning products and air fresheners: exposure to primary and secondary air pollutants. Atmospheric Environment 38:2841-2865

Steinemann AC 2009 Fragranced consumer products and undisclosed ingredients. Environmental Impact Assessment Review 29:32-38

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

Aromatics (coming soon) in Print

I happened across this abstract on the web while browsing around searching for future posts for the aromaconnection blog:

The Scents of Larsa: A Study of the Aromatics Industry in an Old Babylonian Kingdom by Robert Middeke-Conlin | Papers by Robert

Revision of M.A. Thesis Submitted March, 2010. Cuneiform Digital Library Journal (CDLJ) In press,2011
Full version of this paper was removed on January 4, 2011 in preparation for its publication by CDLJ later this year.

The aromatics trade is a luxury trade with origins in distant antiquity. Ancient Mesopotamian and Egyptian techniques at perfume production are the roots of the Arabic perfume industry so famous in the Middle Ages. The south Arabian incense trade, so important to the Greeks and Romans, seemingly appears fully grown with the domestication of the camel. However, this trade and the production of perfumes arose from a much older tradition of which the sources are difficult to grasp. There are no texts which describe perfume production before the Middle Assyrian period, nor did the ancient Mesopotamians state where many of the raw materials they imported came from.
This work sheds light on some of the origins of this trade by examining the aromatics industry as it existed in the Old Babylonian Kingdom of Larsa. Section one lays the groundwork for this discussion, starting with a history of aromatic scholarship, moving on to a textual discussion; and ending by stating both the modern and ancient terms used to describe aromatics and perfumes, as well as defining the use and non use of the šim determinative. Section two describes the manufacture of aromatic products; beginning with an examination of the materials used in production, moving on to an overview of the methods involved in perfume manufacture, then describing the perfumer, and finishing by exploring the places of aromatic production. Section three discusses how aromatics and fragrances fit into the society and economy of the Kingdom of Larsa. This section investigates the sources of aromatic raw materials, the people involved in the aromatics trade, and the availability and uses of aromatics in the Kingdom of Larsa’s society.

I’ve been unable to determine exactly when this will be published, but this will be in an online journal that is available for free. So we’ll plan on a review here once it is out.

Technorati Tags: aromatics Industry History,Aromatics in Babylon

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

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

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

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

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

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

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

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

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

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

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

Rosewood & Guaiacwood oils Controlled Under CITES Appendix II.

by Tony Burfield. March 2010.

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

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

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

Technorati Tags: Rosewood,aniba rosaedora,bulnesia sarmientoi,holywood,guaiacwood oil,guaiyl acetate

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

Melissa Oil & IFRA Policy (cont’d): The Further Details

by Tony Burfield, Cropwatch, 6^th Sept 2009

For previous posts on this topic see here and here.

Preamble

Those of us who have worked in the aroma trade for most of their working lives, have, at times, been highly skeptical of the knowledge & abilities of those unelected officials who would impose baffling & seemingly nonsensical regulations and codes of practice upon the trade. Sometimes we felt that we were being regulated by those who had little in-depth knowledge or experience of the subject - a feeling which has never really gone away.

Perhaps safety-orientated organisations like IFRA would have gained more credibility from some of us old-timers if they had more openly owned up to their previous errors. Yes, we accept that with improvements in experimental design and better techniques, many of IFRA’s earlier (nineteen seventies’) findings on ingredient toxicology are now suspect, or have been superseded. Most importantly, the failure to use rigorously purified aroma chemicals for toxicology testing by researchers reporting to RIFM, and the use of complex botanical materials from non-expertly identified botanical sources, has thrown large sections of IFRA’s previous toxicological findings into doubt since impurities and adulterants have often been responsible for adverse effects rather than the pure ingredients. From a personal standpoint, when you have been drenched in perfume & essential oils on a daily basis for 30-odd years, as many of us at the coalface have, you may feel some intuition (rightly or wrongly) for what aroma materials might be posing any handling risks. This is why many of us laughed openly over IFRA’s Quenching Hypothesis (now discredited). It is why we are still cynical over the disproportionate IFRA classifications of many materials which are supposed to be sensitising, according to the corporate-toxicological methodology involved in the QRA approach. But many of these ingredients indicated as sensitisers have failed to produce any significant numbers of adverse reactions amongst the end-users of fragranced cosmetic & household products in which they occur.

Melissa Oil: Lesson Learned

The curious case of the previous banning of Melissa oil as a fragrance ingredient by IFRA, gave Cropwatch an opportunity to explore IFRA’s ingredient policies in detail (see previous Cropwatch reports). In so many instances, a veil of secrecy obscures the detailed experimental facts on which IFRA/REXPAN ingredient status decisions are made. Following requests by Cropwatch, Robertet Grasse, to their immense credit, were willing to share their toxicological findings on Melissa oil testing, referred to in the RIFM data-base but otherwise not available to the general public. Subsequently we can now clearly see (in our opinion) that there was no good reason to ban Melissa oil from perfumery use in the first place, and a case for its continued restriction is heavily based on Robertet’s evidence, which was not comprehensive across a range of dosages, but based on a strategy to reduce costs. This involved contriving experiments at doses which were likely to produce a positive safety outcome, rather than the prospect of funding a more extensive range of tests proving its skin safety at higher dosages. That’s OK - we can easily deal with this, because it represents the truth. It’s just that IFRA didn’t previously reveal these particular facts about the economic restraints which have materially affected the testing strategies, for this particular ingredient.

Where do we go from here? It is apparent that we need an independent body to openly ascertain the facts about ‘pure’ toxicological science – as against the corporate-funded version of toxicology which we are forced to follow. It is also apparent from the mail that Cropwatch receives that there are other expert opinions out there – why must these individuals be sidelined and denied places on expert committees? Above all, Cropwatch is concerned that the low standards set out in many IFRA commercial standards may be rubber stamped & adopted by the EU Commission, as of course has happened previously, and which may come to be an increasing trend.

Melissa Oil – the Further Details

With a few minor punctuation changes, the reply from Catherine Gadras is set out below (we had asked for the exact botanical identification of the Melissa spp distilled for essential oil (since IFRA had failed to properly define it), and for its’ geographic origin & compositional details. We had further asked the Robertet team for any views on the presented HRIPT & EC3 data. We also had an exchange of mails with Michel Meneuvrier of SAPAD who provided the oil for testing (see below) & who confirmed that the Melissa plants distilled for oil were produced organically from Diois region plants.

Catherine writes:

As I mentioned below Melissa EO used for testing is Melissa officinalis subsp. officinalis L cultivated in the South East of France in the region of Di (Drôme). This genuine essential oil has been provided to us by the SAPAD (Société Anonyme des Plantes Arômatiques du Diois).
The sample was taken from the crop 2008. 7 to 8 levels of fresh leaves plus the flower part are used for the distillation.
Please find below the range of the main constituents provided to us by SAPAD and the composition of the sample used in the most recent tests. (See attached file: Melissa-EO Composition.pdf).[This file consists of the tables included an the end of the post – Ed.]
The crop results from the distillation of 3 cuts: one at the end of May and the two others from the beginning of July and at the end of August/beginning of September. The producer finds that the citral content is maximum in the third cut (greater than 50%) and that citronellal is below 10%.
2) Comments regarding safety data (HRIPT and EC3)
The LLNA has been made to determine a level of concentration at which one begins to observe induction of sensitisation. In our case 4500µg/cm².
Considering the high cost of this EO (5 to 7 tons of fresh plants to
produce 1 Kg of essential oil) on one hand and the fact that we did not want to risk a positive reaction in the HRIPT, we have chosen this conservative 1470µg/cm². 1470µg/cm². This is more than adequate for perfumery use which is our business. It is quite possible that a higher safe limit for melissa EO exists but in my opinion it must be verified by testing my opinion it must be verified by testing.
PS: I take advantage of our e-mail exchanges to make some comments concerning the Cropwatch report on Melissa (page 3) that I found on internet :
I have 2 comments on this sentence below: :
"Under the draft proposals for IFRA’s 44th Amendment, melissa oil (which they describe as ‘genuine Melissa officinalis L.’) has been downgraded from an outright ban in fragrances, to a concentration restriction in the fragrance compound (as opposed to the finished cosmetic product). QRA data for melissa oil, which is categorised as a weak sensitiser, is presented by IFRA for the various established product categories, based on a No Expected Sensitization Induction Level (NESIL) of 1400µg/cm²."

1) Did you really mean "downgraded" ? My poor English would have expected "upgraded". (Cropwatch comments: downgraded from a negative position (a ban) but upgraded to more positive position (just a restriction) - it all depends on how you look at it!).

2) I confirm to you that the QRA limits are in finished consumer products and not in fragrance compounds.” (Cropwatch comments: on this latter point we stand corrected. Thank you Catherine!).

Addenda – Analysis Data received from Robertet.

Analysis of Melissa EO sample used in HRIPT test.

Component	% FID CW
Myrcène	0,16
Limonène	0,37
Cis Ocimène	0,12
Trans Ocimène	1,14
Para cymène	0,15
Methylheptenone 1	1,76
Octène 1 ol 3	0,4
Citronellal	1,3
Alpha copaene	0,34
Beta bourbonene	0,4
Linalool 1,38	1,38
Cis + Trans Isocitral	1,6
Beta Caryophyllene	14,2
Neral	23,8
Methyl geraniate	0,32
Germacrene	4,3
Geranial	33
Geranyl acetate	2,2
Delta Cadinene or delta Amorphene 7	0,7
Citronellol	0,2
Nerol	1,1
Isogeraniol (cis+trans)	0,24
Geraniol	1,7
Epoxydes de caryophyllene (cis+trans)	1,8
Germacradienol	0,3
Muurolol T	0,4
Thymol	2,1
carvacrol	0,25
Alpha Cadinol	0,6
Neric acid	0,1
Geranic acid	0,3
TOTAL 96,73

Information Stat from SAPAD

	Mini %	Maxi%	Moyenne %	Escart Type %
Methyl heptenone	1.05	3.36	1.8	0.7
Limonene	0.04	0.48	0.18	0.13
Citronellal	0.6	19	4.9	4.4
Neral +citronellol	6.4	28	18.7	5.4
Geranial + Geraniol	9	38.3	25.6	7.4
Caryophyllene beta	10.1	29.6	18.3	4.4

Technorati Tags: Melissa officinalis,Melissa,IFRA,Robertet,RIFM

Notes and News

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

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

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