the aromaconnection blog

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cropwatch at the SCS Symposium, Grantham UK, 2009

Tony Burfield gave a talk entitled “Legislators & Natural Aromatics: a Modern Day Vendetta” at the Symposium on Cosmetic Controversies –Seeing the Whole Picture organised by the Society of Cosmetic Scientists, May 17-19th 2009. Power Point and pdf versions of the above presentation can be viewed in the newly reorganised Cropwatch Files section of the Cropwatch website. Matthias Vey of IFRA spoke immediately after Cropwatch, his talk being entitled “How Safe are Fragrance Raw Materials? The IFRA Principles for Safety Assessment.” In the interests of balance, we hope it eventually becomes possible to run both talks side by side, and for both parties to answer the other’s criticisms.

Looking to the future, Cropwatch has plans to become a funded operation later this year. Although we continue to expand our available data on natural products on the Cropwatch website, and to attract new Cropwatch Newsletter subscribers, and we continue to regularly receive pledges of support from many quarters, we feel that there is a limit to what can be practically achieved without funding. Our intention therefore is to run a series of courses in order to raise the necessary finance, which is to be spent on research into some of the contentious areas of aroma ingredient toxicity, which Cropwatch has previously identified. We hope to be able to announce the subjects and venues for the courses in due course.

Tony Burfield
Cropwatch.

Technorati Tags: Cropwatch,Natural aromatics,aromatics regulation,perfumery regulation,IFRA

Notes and News

• Organic Monitor reports that there is an increase in the acreage of organic citrus groves in Florida. They focus on juice, but this should lead to better availability of organic citrus oils. 
• The C.A.M. Report has resurrected the Lavender/Tea Tree Gynecomastia issue again, by reposting an old post from 2007 without updating it to include information about challenges to the original research. 
• In the same post the C.A.M. report mentioned (without citation) a report that in 2005 essential oils were linked to 7,282 reports to poison control centers. UPDATE: JR forwarded the citation in a comment. He reported on this in the C.A.M. Report here. The article cited was here. The original source (PDF) of the data was the 2005 report of the American Association of Poison Control Centers.
• A new blog on food and local agriculture has been added to our Agriculture Horticulture link roll: La Vida Locavore.  Worth checking out if you like food.

Aromatherapy May Make You Feel Good, But It Won't Make You Well

Or so says a study by researchers at the Ohio State University that is spreading rapidly throughout the Main Stream Media and the Internet and is being cited as proof that aromatherapy doesn't work. Although I found it first on a blog about the convergence of Mormon beliefs and science, a little searching revealed that it has been extensively reported on MSM web sites and the OSU Press Release describing the study has been widely reprinted (621 Google hits for the title above), the most significant of which is ScienceDaily.

The study, published online in the journal Psychoneuroendocrinology, looked for evidence that such aromas go beyond increasing pleasure and actually have a positive medical impact on a person’s health.  While a massive commercial industry has embraced this notion in recent decades, little, if any, scientific proof has been offered supporting the products’ health claims.

This could have as wide spread a circulation as the NEJM article on Gynecomastia which has been discussed extensively on this blog a year ago. And unfortunately, as happened in the prior situation, there will probably be very little coverage of any intelligent criticism or further discussion that we might have about the results of the study.

Most of the wider media coverage is based on the press release, and it's likely that very few persons will read the actual study, because of the exorbitant fee charged to download a copy. The aromaconnection blog has sprung for the cost and I have actually read the paper. I'll need a couple of days to digest it but we will definitely be commenting further on it. My initial evaluation is that the methodology is valid, but that a study that is limited to only two essential oils is not the same thing as "Aromatherapy", but of course over-generalizations have never been rare in the media world or the Internet.

The abstract/summary of the paper is:

Despite aromatherapy's popularity, efficacy data are scant, and potential mechanisms are controversial. This randomized controlled trial examined the psychological, autonomic, endocrine, and immune consequences of one purported relaxant odor (lavender), one stimulant odor (lemon), and a no-odor control (water), before and after a stressor (cold pressor); 56 healthy men and women were exposed to each of the odors during three separate visits. To assess the effects of expectancies, participants randomized to the “blind” condition were given no information about the odors they would smell; “primed” individuals were told what odors they would smell during the session, and what changes to expect. Experimenters were blind.

Self-report and unobtrusive mood measures provided robust evidence that lemon oil reliably enhances positive mood compared to water and lavender regardless of expectancies or previous use of aromatherapy. Moreover, norepinephrine levels following the cold pressor remained elevated when subjects smelled lemon, compared to water or lavender. DTH responses to Candida were larger following inhalation of water than lemon or lavender. Odors did not reliably alter IL-6 and IL-10 production, salivary cortisol, heart rate or blood pressure, skin barrier repair following tape stripping, or pain ratings following the cold pressor.

If you'd like to find the paper on the Internet, you can find it on ScienceDirect by entering the keyword Aromatherapy. Right now it is the first entry.

NEJM Gynecomastia Article now available for free

Just a note that the original article (February 2007) in the New England Journal of Medicine on Prepubertal Gynecomastia Linked to Lavender and Tea Tree Oils is now available here for free online. Apparently NEJM locks things up for about a year before publishing them at no charge. I imagine we will see another spate of media interest.

 

Technorati Tags: Lavender and Tea Tree Oils

Knight Science Journalism Tracker » USA Today: Should we all worry over estrogen-mimicking pthalates, bisphenol A, etc? (A: looks like it)

This article summary of a USA Today article suggests that the tide of scientific opinion on pthalates is turning towards concern about their effects.  Long time readers of this blog will remember last February when there was an attempt to blame gynecomastia (enlarged breasts) on lavender and tea tree oil. At the time many of us wondered if perhaps some other ingredients of the materials or packaging might have caused the effects noted. I did a literature search on pthalates but could only conclude that there were lots of opinions on both sides of the issue. Eventually the gynecomastia question will need to be revisited to reach valid conclusions about whether essential oils or other factors were actually the causative.

Lavender-Tea Tree Oil-gynecomastia Response to NEJM Article

The New England Journal of Medicine has published (subscription or purchase required) (h/t Tony B) several Letters to the Editor in its June 14 issue regarding the paper "Prepubertal Gynecomastia Linked to Lavender and Tea Tree Oils" originally published earlier this year and extensively covered in the world media and extensively blogged about on the aromaconnection blog. The four letters from six authors make a number of points, including the following pastiche (paraphrased unless in quotes) drawn from all the letters:

Product names were not reported, raising concerns about what was actually present. There was no examination of alternate processes that might have caused the gynecomastia. Traditional uses or these oils have not suggested estrogenic effects. In vitro testing alone is not adequate to indict products. The estrogenic effects reported indicate a very weak effect. The tea tree effects were not separated from the lavender and "There is no rational process that could allow the authors to conclude that tea tree caused the gynecomastia. . ." "the estrogenic activity . . . was dose dependant." The effects became positive at levels at least 600,000 times the level of the positive control. "Testing was far from comprehensive." "The study . . . does not support a causative link . . ." The study was uncontrolled with other agents possibly having a role. ". . . an average 20-kg child would had to have used 40 bottles of shampoo for each application. The claim of a causative link . . . appears to be misleading and unwarranted."

The authors were given the opportunity to reply and fell back on the usual excuses: we used the ingredients list on the bottle; we didn't know about/find other research; some of the critics sell the stuff and therefore are scoundrels; other variables that we ignored might have been a factor; yes, our findings should be interpreted carefully; yes, there should be more research.

Not surprisingly, the publishers of the some 22,700 articles on the original paper that show up on Google appear to have overlooked the new information and discussion. That is because the there was no press release to raise it from obscurity and the limited access of NEJM economics that require payment to read it.

ATTIA Demands retraction of Gynecomastia Paper

In a press release issued on February 21 ATTIA, the Australian Tea Tree Industry Association, called for a retraction of claims that tea tree oil may have contributed to the growth of breasts in prepubesent boys in the paper Prepubertal Gynecomastia Linked to Lavender and Tea Tree Oil. (published: New England Journal of Medicine 365 (5) pp 480-485 D. V. Henley, Ph. D., Natasha Lipson, M. D., Kenneth S. Korach, Ph. D. and Clifford A. Bloch, M. D.)

In a hard-hitting critique of the paper, after consultation with numerous research scientists, Christopher Dean, chairman of their Technical and Safety Committee not only completely debunks the study, but raises the issue of media responsibility that many people have been concerned about. It appears that reporters interviewing the scientists about the paper were more interested in finding out things that would sell newpapers than in finding out factual information.

As we have previously reported in this blog, the original paper and the articles about it created a media sensation and spread rapidly throughout the world via print media and the Internet. Blogs and newspapers kept picking up the articles and reporting the information as fact, usually omitting mention of the author's ambivalence about their results. But you can bet it will be very difficult to refute the media reports, since it would take a concerted effort by many people to contact all the newspapers via letters to the editor and to leave comments on all the blogs that have carried the story (particularly since many of them don't even accept comments).

This press release and other information published by Robert Tisserand and others provide the information that is needed to refute the original media furor. But as experience with the mainstream media demonstrates, it may not be easy to get the media to pay any attention.  Even if they do issue a retraction it will be on page A18, noticed by few and ignored by the rest.

But that does not deter the folks at ATTIA, and it should not deter us. We should be writing letters to the Editor and posting comments on blogs. Point people to the links in this article while raising the question of whether the information as reported by the media was correct. Check Google News to find out where the articles are on line. Currently there are 421 hits for Lavender and Tea Tree, which seems to give the most consistent set of articles -- with only two pointing out that the articles are incorrect.

It seems unlikely that the NEJM would actually retract the article, since what the scientific process is all about is publishing information so that others can agree with it or refute it. But ATTIA believes that they should, concluding their press release:

This publication is, to say the least, unscientific. The conclusion stated in the summary is not supported by the cell culture studies. The authors show no curiosity at all about the enormous difficulties in attempting to connect the cell culture studies with the case studies scientifically. It is disappointing to see the New England Journal Of medicine publishing such work uncritically, allowing such material to damage its own reputation and to create unwarranted alarm and commercial damage around the world. A retraction is warranted.

Lavender/Tea Tree Study Debunked

Neither lavender oil nor tea tree oil can be linked to breast growth in young boys

Robert Tisserand

Background

In a recent report, a correlation is alleged between commercial products containing lavender and tea tree oils and breast growth in young boys. Three cases were seen in boys aged 4-7, who had all been using such products. In each case, the breast growth reduced to normal parameters within several months of ceasing to use the products. Subsequent laboratory testing showed that both essential oils had estrogen-like properties (Henley et al 2007).

In the report, no information is given about any of the constituents of the products used. The information given about product use is sparse, and we do not know for certain whether any of the products contained lavender or tea tree oils, since they were not analyzed by the researchers.

The cases

Case one
In the first case, "The patient’s mother reported applying a "healing balm" containing lavender oil to his skin starting shortly before the initial presentation." No further details of the product or its use are given, but a healing balm sounds like something that might only be applied to a small area of skin. If so, then it is unlikely that any ingredient could have entered the boy’s blood in sufficient concentration to cause gynecomastia within a short time period.

Case two
In the second case, a styling hair gel was applied to the hair and scalp every morning, along with regular use of a shampoo. Both tea tree and lavender oil are cited on the ingredient list of both products.

In a subsequent website report, it is claimed that the two hair products used in this case were manufactured by Paul Mitchell, and that these were analyzed by a competitor. The shampoo was said to contain "very low concentrations" of tea tree oil, and the content in the hair gel was "virtually undetectable". Lavender oil concentration was not checked (Neustaedter 2007).

Dermal absorption of fragrance from shampoo application has been estimated to be 80 times less than that from body lotion (Cadby et al 2002). If the website report is genuine, considering that shampoo is a wash-off product, and that there was only a negligible amount of tea tree oil in the hair gel, tea tree oil can be ruled out as a possible cause of this boy’s gynecomastia. However, liberal use of a hair gel rich in lavender oil could result in moderate dermal absorption of lavender oil constituents (Cal 2006).

Case three
The third case involved "lavender-scented soap, and intermittent use of lavender-scented commercial skin lotions". This sounds as if there may not be very much natural lavender oil present. Further, soap is a wash-off product, and the use of lavender lotion is described as "intermittent". Whether any absorption of genuine lavender oil took place at all seems doubtful.

Since dermal absorption of soap fragrance is some 266 times less than that from body lotion, it is  virtually impossible that the fragrance in a soap could be absorbed in sufficient quantity to cause any physiological effect (Cadby et al 2002).

Of great interest is the statement that, in this third case, a fraternal twin used the same skin lotions, but not the soap, and did not develop gynecomastia. It would be reasonable to assume that, since the soap could not be responsible for the effect, and since the twin used the lotions without any problem, the gynecomastia in this third case must have been due to some cause other than essential oils.

The in vitro testing

The in vitro evidence shows weak but definite endocrine disrupting effects for both lavender and tea tree oils. The second case was the only one in which tea tree oil was involved. Tea tree oil was tested because it was deemed to be "chemically similar" to lavender oil. However, apart from the fact that both are essential oils, they have little in common chemically.

The composition of the essential oils tested is not given, nor is any other information about them, apart from the supplier. Since they do not appear to be organically grown, biocide content is a possibility.

Discussion

It is unusual in such reports not to name the products suspected as being responsible for the effects under discussion. In the circumstances, it is also curious that the labeled ingredients were not cited. It is even more surprising that no attempt was made to ascertain, retrospectively, whether any constituents of lavender or tea tree oil were detectable. If the products are not named, no one else can test them either.

Even assuming that one or both of the essential oils were present at some level, we do not know what quantities of essential oil constituents may have penetrated the skin, but we do know that transcutaneous absorption from fragrances takes some time. The amount that could find its way into the blood from a wash-off product such as a shampoo or soap is negligible, because the time of skin contact is so short. Skin absorption from tea tree and lavender oil constituents is measured in hours, not minutes, in and some instances even leave-on products result in minimal dermal penetration (Cal 2006, Reichling 2006).

The Henley et al report mentions that none of the boys had been exposed to any known endocrine disruptor, such as medications, oral contraceptives(!), marijuana or soy products. However, no mention is made of other known endocrine disruptors, such as organochlorine pesticides, PCBs, polychlorinated dioxins, alkyl phenols, pthalates and parabens (Darbre 2006). Both pesticides and phthalates have been found in essential oils, and both phthalates and parabens are commonly found in cosmetic products.

It is, therefore, entirely possible that other ingredients in the products caused the gynecomastia. Pesticides, PCBs and dioxins are found in the environment, often in food, and it is also possible that some local surge of environmental hormone disruptors caused these cases in Colorado.

No attempt was made to identify the constituent(s) responsible for the in vitro effect, but it is reasonable to expect that any hormonal action in an essential oil would be due to one or two constituents, or even contaminants. It is noteworthy that, while in vitro hormonal effects from essential oil constituents have been previously reported, these are generally very weak, and have been estimated as being at least 10,000 times less potent than 17β-estradiol (Howes et al 2002).

There is no evidence that the effect seen in vitro would take place in vivo, and much more research would be needed before any definite determinations could be made. Many estrogenic substances have previously been identified from plant sources, and very weak activity is typical of these phytoestrogens (Chadwick et al 2006, Howes et al 2002).

Conclusions

As the report states, breast growth in pre-pubertal boys is extremely uncommon, yet three cases are reported within a short period of time, and all in the same clinic. Considering that some 200 tonnes per annum are produced of both lavender and tea tree oil, that most of this goes into personal care products, and that very little of the evidence presented for these 3 cases is convincing, the press reports of caution are premature.

Even if one or more of these cases was linked to product use, any connection with either lavender or tea tree oil is unproven. Other known endocrine disrupting ingredients in the products could have played a role. Furthermore, we do not know what other factors, such as dietary or environmental, may have played a part.

The in vitro work reported by Henley et al (2007) does indicate a hormonal effect. However, this cannot be extrapolated to estimate actual human risk, especially without knowing more about the essential oil constituents causing the in vitro effects seen. No connection was established between the in vitro work and the three cases, and the case for tea tree oil having an effect on prepubertal gynecomastia is especially weak. Phytoestrogens generally have a very weak hormonal activity, and it is implausible that the amounts of essential oil that enter the body from product use would have a significant effect. Further research will hopefully clarify these issues.

References

Cadby PA, Troy WR, Vey MG 2002 Consumer exposure to fragrance ingredients: providing estimates for safety evaluation. Regulatory Toxicology & Pharmacology 36: 246-252

Cal K 2006 How does the type of vehicle influence the in vitro skin absorption and elimination kinetics of terpenes? Archives of Dermatological Research 297: 311-315

Chadwick LR, Pauli GF, Farnsworth NR 2006 The pharmacognosy of Humulus lupulus L. (hops) with an emphasis on estrogenic properties. Phytomedicine 13: 119-131

Darbre PD 2006 Environmental oestrogens, cosmetics and breast cancer. Best Practice & Research Clinical Endocrinology & Metabolism 20: 121-143

FMA 2007 http://www.fmafragrance.org/sub_pages/020107henleyresponse.pdf

Henley DV, Lipson N, Korach KS, Bloch CA 2007 Prebubertal gynecomastia linked to lavender and tea tree oils. New England Journal of Medicine 365(5): 479-485

Howes M-J R, Houghton P J, Barlow D J et al 2002 Assessment of estrogenic activity in some common essential oil constituents. Journal of Pharmacy & Pharmacology 54:1521–1528

Neustaedter R 2007 http://www.cureguide.com/Natural_Health_Newsletter/Lavender_Dangers/lavender_dangers.html

Reichling J, Landvatter U, Wagner H, Kostka KH, Schaefer UF 2006 In vitro studies on release and human skin permeation of Australian tea tree oil (TTO) from topical formulations. European Journal of Pharmaceutics & Biopharmaceutics 64: 222-228

Contact: Robert Tisserand

Email:[email protected]