"Is excessive "Is excessive regulation regulation

destroying the destroying the perfumery art?"perfumery art?"

by Tony Burfieldby Tony Burfield

Cropwatch Cropwatch

www.cropwatch.orgwww.cropwatch.org

Logo: Juniperus procera Hochst. ex Endl. (Kenyan Cedarwood):

Over-Exploited to Near Extinction by the E.O. Trade.

Who are Cropwatch?Who are Cropwatch? A loosely based, non-financed, independent A loosely based, non-financed, independent

watch-dog to the aroma & natural products watch-dog to the aroma & natural products trade. trade. In existence approx 6-7 years.In existence approx 6-7 years.

BestBest known for its pro-active campaigning known for its pro-active campaigning activities on natural aromatics, data-bases activities on natural aromatics, data-bases on threatened aromatic species & bio-on threatened aromatic species & bio-piracy, long-term opposition to the piracy, long-term opposition to the 26 26 allergensallergens legislation, & to the QRA (which legislation, & to the QRA (which the SCCP has also criticised in the SCCP has also criticised in SCCP/1153/08). .

No formal membership; produces an No formal membership; produces an occasional occasional CropwatchCropwatch NewsletterNewsletter which which reaches some 40,000 people.reaches some 40,000 people.

Provides free information on natural Provides free information on natural aromatics on its website aromatics on its website www.cropwatch.orgwww.cropwatch.org and free advice to enquirers.and free advice to enquirers.

Part I – Perceived Part I – Perceived Problems with Problems with

Fragrance Safety Fragrance Safety Legislation Legislation

& Safety ‘Experts’.& Safety ‘Experts’.

Safety Issues in the Aroma Safety Issues in the Aroma Business.Business. Fragrance customers usually insist on adherence to Fragrance customers usually insist on adherence to allall

existing H&S guidelines (both official & voluntary) existing H&S guidelines (both official & voluntary) because of the prevailing fear-culture, and possible because of the prevailing fear-culture, and possible media exposure regarding potential adverse effects to media exposure regarding potential adverse effects to end-users from single ‘hazardous’ fragrance end-users from single ‘hazardous’ fragrance ingredients. ingredients.

EU Regulators have no capability of gauging the socio-EU Regulators have no capability of gauging the socio-economic effects of their policies. Banning or economic effects of their policies. Banning or restricting natural aromatic materials often has severe restricting natural aromatic materials often has severe economic consequences for natural aromatic economic consequences for natural aromatic producers and dependent communities in developing producers and dependent communities in developing countries. Disastrous EU legislation is (sometimes) countries. Disastrous EU legislation is (sometimes) followed by an impact assessment and (then possibly) followed by an impact assessment and (then possibly) corrective action – but by then its often too late to save corrective action – but by then its often too late to save any affected SME’s (e.g. the effect of the BPD on any affected SME’s (e.g. the effect of the BPD on Europe’s natural biocidal product manufacturers).Europe’s natural biocidal product manufacturers).

Knowledgeable whistle-blowers revealing questionable Knowledgeable whistle-blowers revealing questionable trade practices are shunned by the trade (for example, trade practices are shunned by the trade (for example, as detailed in the letters of the late Stephan Arctander).as detailed in the letters of the late Stephan Arctander).

Safety Issues in the Aroma Safety Issues in the Aroma

Business Business cont’d.cont’d. So many SME’s (candle-makers / soap-makers/ So many SME’s (candle-makers / soap-makers/ incense traders / pot pourri makers / hand-made incense traders / pot pourri makers / hand-made cosmetics makers / general cleaning product makers cosmetics makers / general cleaning product makers / natural perfumers / aromatherapists etc.) cannot / natural perfumers / aromatherapists etc.) cannot afford IFRA / RIFM’s annual fees, & so are locked afford IFRA / RIFM’s annual fees, & so are locked out of access to a lot of detailed safety data. out of access to a lot of detailed safety data.

Perfume manufacturing orgs. require the implicit Perfume manufacturing orgs. require the implicit adherence of their members to IFRA Standards & adherence of their members to IFRA Standards & CoP [note: these are not CoP [note: these are not legallegal requirements, with the requirements, with the exception of Eco-label fragrances]. However many exception of Eco-label fragrances]. However many traditional perfumes types, as well as natural, traditional perfumes types, as well as natural, organic & functional perfumes are almost impossible organic & functional perfumes are almost impossible to construct under existing IFRA regulations. to construct under existing IFRA regulations.

Safety data is often generated by the major aroma Safety data is often generated by the major aroma corporates in an atmosphere of secrecy & may have corporates in an atmosphere of secrecy & may have private ownership issues attached; private ownership issues attached; data can be data can be difficult to locate, & expensive or virtually difficult to locate, & expensive or virtually impossible for the general public to obtain. impossible for the general public to obtain. There is There is also a lack of transparency by regulatory also a lack of transparency by regulatory professionals. professionals.

Healthy factory Healthy factory environments: environments:

at least, nobody ever caught at least, nobody ever caught a cold!a cold!

The ‘Zero Risk Mindset’.The ‘Zero Risk Mindset’. EU Regulators EU Regulators applyapply - (or - (or appearappear toto have have

been pressurised into,been pressurised into, by ‘invisible’ by ‘invisible’ lobbyistslobbyists) a disproportionate & excessive ) a disproportionate & excessive degree of regulation wrt aromatic degree of regulation wrt aromatic ingredients, which appears to be an attempt ingredients, which appears to be an attempt to construct a clean, risk-free and largely to construct a clean, risk-free and largely synthetic-based world of their ownsynthetic-based world of their own. That is . That is not the world that most of us wish to inhabit, not the world that most of us wish to inhabit, and Cropwatch believes that many will and Cropwatch believes that many will ignore any restrictions which deny us the use ignore any restrictions which deny us the use of those familiar natural materials which we of those familiar natural materials which we associate with our lives, our heritage & our associate with our lives, our heritage & our traditions.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 So How Dangerous is it to go Outside…?Outside…? The green leaves of trees & plants continuously The green leaves of trees & plants continuously

emit emit - & - & -pinenes, limonene etc. -pinenes, limonene etc. Shenck (1979) Shenck (1979) estimated that 438 million tons of monoterpenes* estimated that 438 million tons of monoterpenes* evaporate into the air continually from biological evaporate into the air continually from biological materials materials [*natural monoterpenes that are [*natural monoterpenes that are designated ‘designated ‘dangerous for the environmentdangerous for the environment’’]. It ’’]. It has been calculated that one European forest puts has been calculated that one European forest puts more chemicals into the environment that the more chemicals into the environment that the whole EU chemical industry. whole EU chemical industry.

Emitted leaf volatiles also react with ozone to form Emitted leaf volatiles also react with ozone to form irritating / sensitising terpene epoxides. Some US irritating / sensitising terpene epoxides. Some US fragranced home-care products containing fragranced home-care products containing limonene are labelled (paraphrasing): limonene are labelled (paraphrasing): do not use if do not use if smog outside smog outside ! !

Tree leaf volatiles also react with nitrogen oxides Tree leaf volatiles also react with nitrogen oxides from combustion engine emissions causing from combustion engine emissions causing chemical smogs. Academics at Lancaster chemical smogs. Academics at Lancaster University (2002) recommended that UK councils University (2002) recommended that UK councils modify the planting of certain VOC emitting trees modify the planting of certain VOC emitting trees (maple trees: good; oaks & poplars: bad!) (maple trees: good; oaks & poplars: bad!) (not, (not, you will notice, take any steps to stop cars you will notice, take any steps to stop cars emitting nitrogen oxides).emitting nitrogen oxides).

Nature: Presents More Nature: Presents More Hazards than Using Hazards than Using

Fragranced Products?Fragranced Products? Inhalation of fern spores poses a cancer risk Inhalation of fern spores poses a cancer risk

to countryside visitors / dwellers, & the to countryside visitors / dwellers, & the spores are also a risk to the safety of potable spores are also a risk to the safety of potable water supplies (Calif. Prop 65). water supplies (Calif. Prop 65).

Unregulated nuisance farm crops such as Unregulated nuisance farm crops such as mustard seed-rape (flowers & roots) emit allyl mustard seed-rape (flowers & roots) emit allyl isocyanate, benzyl cyanide etc. into the air & isocyanate, benzyl cyanide etc. into the air & soil. Aerial dispersion causes respiratory soil. Aerial dispersion causes respiratory distress / allergy to many in vicinity (see distress / allergy to many in vicinity (see Rapeseed report: Rapeseed report: Cropwatch FilesCropwatch Files). ).

This is not to mention the unregulated intake This is not to mention the unregulated intake of natural carcinogens, mutagens, toxins etc. of natural carcinogens, mutagens, toxins etc. consumed in food & spices, & beverages (e.g. consumed in food & spices, & beverages (e.g. methyl eugenol from pesto, safrole from methyl eugenol from pesto, safrole from nutmeg, and the CMR1 substance ethanol). nutmeg, and the CMR1 substance ethanol).

Crop of Unregulated Allyl Crop of Unregulated Allyl Isocyanate & Benzyl Isocyanate & Benzyl

Cyanide Emitters (Cyanide Emitters (Brassica napus L. ssp. oleifera).

Forest of Unregulated Forest of Unregulated - & - & --Pinene Emitters (Pinene Emitters (PinusPinus sp.), sp.),

Finland, near Local Aquifer! (can Finland, near Local Aquifer! (can you spot the you spot the DaphniaDaphnia?)?)

Unregulated Phenylacetaldehyde Unregulated Phenylacetaldehyde Emitters Emitters Lotus corniculatusLotus corniculatus L.L.

ggrowing in the Shetlands!rowing in the Shetlands!

Unregulated Wild-Flower Unregulated Wild-Flower Coumarin Source Coumarin Source

((Melilotus officinalis Melilotus officinalis LL..).).

Unregulated Plateful of Unregulated Plateful of Suspected Rodent Carcinogen Suspected Rodent Carcinogen

posing as Foodstuff.posing as Foodstuff.

REACH.REACH. Industry is seen as a cash-cow by the EU H&S Industry is seen as a cash-cow by the EU H&S

Commission. REACH registration costs will potentially Commission. REACH registration costs will potentially ruin all but the largest aroma concerns, in spite of ruin all but the largest aroma concerns, in spite of concessions for SME’s. concessions for SME’s. The aroma industry magnates The aroma industry magnates therefore divisively support the REACH regulations as a therefore divisively support the REACH regulations as a means of eliminating competition.means of eliminating competition.

The ECHA has created an unmonitored situation under The ECHA has created an unmonitored situation under REACH (e.g. for lead registrants & for SIEFS etc.) where REACH (e.g. for lead registrants & for SIEFS etc.) where bullying and mafia-like activity by large aroma industry bullying and mafia-like activity by large aroma industry corporates has gone unrestricted. corporates has gone unrestricted.

REACH will severely reduce the available portfolio of REACH will severely reduce the available portfolio of fragrance ingredientsfragrance ingredients – Western companies will only be – Western companies will only be able to make ‘Mickey Mouse’ perfumes.able to make ‘Mickey Mouse’ perfumes.

REACH has already driven the focus of activity of leading REACH has already driven the focus of activity of leading trans-international aroma companies out of Europe. trans-international aroma companies out of Europe.

Leading toxicologists are opposed to REACH (see next Leading toxicologists are opposed to REACH (see next slide) slide)

The Basis of REACH The Basis of REACH challengedchallenged The idea that the toxic effects of a chemical show a The idea that the toxic effects of a chemical show a

dose-dependent linear relationship ending at a dose-dependent linear relationship ending at a threshold level is now challenged: at low levels threshold level is now challenged: at low levels adaptive, non-adverse or even beneficial effects adaptive, non-adverse or even beneficial effects occur (occur (hormesishormesis), and have been shown for >6,000 ), and have been shown for >6,000 chemicals (Calabrese 2004). chemicals (Calabrese 2004).

This raises a ‘serious misreading of the term toxic’ This raises a ‘serious misreading of the term toxic’ charge for the EPA, and for the ECHA over the charge for the EPA, and for the ECHA over the REACH legislation, and suggests that the 50-100 REACH legislation, and suggests that the 50-100 million Euros spent on the exercise is wasted, and million Euros spent on the exercise is wasted, and will not save a single life. will not save a single life.

The above reference to the EPA needs to be seen as The above reference to the EPA needs to be seen as what appears to be what appears to be a gagging ordera gagging order, mentioned a , mentioned a document prepared by the EPA in 2004, which states document prepared by the EPA in 2004, which states that the purpose of a risk assessment is to identify that the purpose of a risk assessment is to identify risk (harm, adverse effect etc.), risk (harm, adverse effect etc.), effects that appear to effects that appear to be adaptive, non-adverse or beneficial may not be be adaptive, non-adverse or beneficial may not be mentioned. mentioned. - through Calabrese (2007) ”Belle Newsletter: - through Calabrese (2007) ”Belle Newsletter: Introduction. “ Introduction. “ Human & Experimental ToxicologyHuman & Experimental Toxicology 2626, 845., 845.

The importance of The importance of natural aromatic natural aromatic

ingredients.ingredients. Naturals Naturals breathe life into an otherwise simple breathe life into an otherwise simple blend of chemicals, adding depth and blend of chemicals, adding depth and sophistication - whether floral absolutes, sophistication - whether floral absolutes, woody materials or citrus oils are employed woody materials or citrus oils are employed (many of these ingredients will disappear under (many of these ingredients will disappear under REACH).REACH).

Whole fragrance styles / families would not exist Whole fragrance styles / families would not exist without naturals – for example, without naturals – for example, Eau de ColognesEau de Colognes, , Eau FraichesEau Fraiches..

Many landmark fragrances & fragrance styles Many landmark fragrances & fragrance styles owe their conception to key natural materials owe their conception to key natural materials e.g. the e.g. the chyprechypre style of style of MitsoukoMitsouko & & Miss DiorMiss Dior, , which were based on accords of oakmoss, which were based on accords of oakmoss, patchouli oil and labdanum together with patchouli oil and labdanum together with bergamot oil. bergamot oil.

Many  essential oils lend an incomparable radiant Many  essential oils lend an incomparable radiant freshness to fragrances e.g. lime, lavender & freshness to fragrances e.g. lime, lavender & petitgrain. It is hard to imagine an impressive petitgrain. It is hard to imagine an impressive masculine fine fragrance which merely relies on masculine fine fragrance which merely relies on synthetic materials for its freshness. synthetic materials for its freshness.

A Timid Industry.A Timid Industry. Cosmetic / biocidal / detergent & cleaning ingredient Cosmetic / biocidal / detergent & cleaning ingredient

restrictions & regulation proceed with little effective restrictions & regulation proceed with little effective trade questioning or objection in the EU, leading to trade questioning or objection in the EU, leading to questions about why industry is so timid (see questions about why industry is so timid (see Durodie 2004).Durodie 2004).

But ‘the worm is turning’. In the US, cosmetics-But ‘the worm is turning’. In the US, cosmetics-based SME’s are grouping together to prevent based SME’s are grouping together to prevent financially discriminating legislation acting against financially discriminating legislation acting against them – for example over the crippling fees & costs them – for example over the crippling fees & costs involved with compliance to the FDA Globalisation involved with compliance to the FDA Globalisation Act HR-759, 2009). The Act HR-759, 2009). The Colorado Safe Personal Colorado Safe Personal Products ActProducts Act HB-1248 which proposed zero HB-1248 which proposed zero tolerance for many ‘hazardous’ single cosmetic tolerance for many ‘hazardous’ single cosmetic ingredients (& so was potentially ingredients (& so was potentially even more extremeeven more extreme than existing European legislation) failed in than existing European legislation) failed in committee (01.03.2010) due to pressure from SME’s.committee (01.03.2010) due to pressure from SME’s. In S.E. Asia, producers of natural aromatic materials In S.E. Asia, producers of natural aromatic materials & cosmetics are just starting (Feb 2010) to form anti-& cosmetics are just starting (Feb 2010) to form anti-regulation groups to protect their livelihoods. regulation groups to protect their livelihoods.

Shortcomings of the EU Shortcomings of the EU Cosmetic Commission’s Cosmetic Commission’s

H&S Policies.H&S Policies. The EU Cosmetics Commissions’ CoP refuses to The EU Cosmetics Commissions’ CoP refuses to

define ‘safety’, there is no individual define ‘safety’, there is no individual ingredient risk quantification, it does not ingredient risk quantification, it does not consider ingredient risk / benefit consider ingredient risk / benefit considerationsconsiderations (except for preservatives), it (except for preservatives), it does not allow in-use considerations, & it does does not allow in-use considerations, & it does not allow for end-consumer adverse reaction not allow for end-consumer adverse reaction statistics to affect safety policy - as apparently statistics to affect safety policy - as apparently this is not ‘bona fide’ evidence (this is not ‘bona fide’ evidence (Daskaleros 2007). .

This ‘risk-only’ chemophobic scenario leads to This ‘risk-only’ chemophobic scenario leads to a state of a state of toxicological imperialismtoxicological imperialism, where , where over-precaution & scare-mongering are over-precaution & scare-mongering are de de rigueurrigueur, and where pharmaceutical & chemical , and where pharmaceutical & chemical company lobbying disadvantages competitive company lobbying disadvantages competitive natural products. Worrying situations of natural products. Worrying situations of vested interest (e.g. in the SCC(S)(P)) remain vested interest (e.g. in the SCC(S)(P)) remain unaddressed. unaddressed. Europe has become a hostile Europe has become a hostile environment for perfumery; many concerns environment for perfumery; many concerns have re-located outside the EU. have re-located outside the EU.

A Lack of Cross-Disciplinary A Lack of Cross-Disciplinary Expertise..Expertise.. EU Cosmetic Comm. staff admitted to Cropwatch EU Cosmetic Comm. staff admitted to Cropwatch

(Brussels 2007) they were (Brussels 2007) they were unable to find the unable to find the services of a botanical expertservices of a botanical expert, and the , and the SCCPSCCP had no had no literature searchliterature search abilityability until 2007until 2007 (& so previously (& so previously could not properly independently review the could not properly independently review the evidence presented to them). Now a pool of 160 evidence presented to them). Now a pool of 160 ’experts’ is supposedly to be made available to ’experts’ is supposedly to be made available to Brussels staff (but no word on any botanists!).Brussels staff (but no word on any botanists!).

The previous safety assessments of many / most The previous safety assessments of many / most natural fragrance ingredients by RIFM have natural fragrance ingredients by RIFM have proceeded via industrially donated materials which proceeded via industrially donated materials which have not been have not been botanically identified at source by an botanically identified at source by an expert, were not batch-tracked and not proven as expert, were not batch-tracked and not proven as 100% derived from the named botanical. The lack of 100% derived from the named botanical. The lack of forensic and taxonomic application has led forensic and taxonomic application has led Cropwatch to describe a number of IFRA Standards Cropwatch to describe a number of IFRA Standards as non-robust, where botanical identifications (as as non-robust, where botanical identifications (as published) are either published) are either incorrect, incomplete or based incorrect, incomplete or based on false assumptions of ingredient purityon false assumptions of ingredient purity e.g. for e.g. for opoponax (see opoponax (see Cropwatch Files - OpoponaxCropwatch Files - Opoponax).).

..and a Lack of Ecological ..and a Lack of Ecological Awareness..Awareness.. The industrial over-exploitation of many natural The industrial over-exploitation of many natural

aromatic species by the Cosmetics & aromatic species by the Cosmetics & Pharmaceutical industries remains virtually Pharmaceutical industries remains virtually unchecked – unchecked – by the time a CITES listing or an IUCN by the time a CITES listing or an IUCN Red Listing is in place, it is often too lateRed Listing is in place, it is often too late to save the to save the speciesspecies under threat, or the full compliment of its’ under threat, or the full compliment of its’ genetic diversity. genetic diversity.

For example while IFRA pondered a new Standard For example while IFRA pondered a new Standard for styrax qualities, less than 15 hectares of Asian for styrax qualities, less than 15 hectares of Asian styrax trees remained unlogged in Turkey. styrax trees remained unlogged in Turkey.

Commodities from rare or threatened species Commodities from rare or threatened species include: agarwood oil, sandalwood oil East Indian, include: agarwood oil, sandalwood oil East Indian, sandalwood oil East African, rosewood oil, sandalwood oil East African, rosewood oil, Cedrela Cedrela odorata odorata oiloil, , guaiacwood oil, copaiba balsam, gurjun guaiacwood oil, copaiba balsam, gurjun balsam, candeia plant spp., costus qualities, balsam, candeia plant spp., costus qualities, ParmeliaParmelia (fragrant lichen) qualities, some (fragrant lichen) qualities, some frankincense yielding spp. e.g. frankincense yielding spp. e.g. BoswelliaBoswellia papyrifera, papyrifera, chaulmoogra oil and many others (see Cropwatch chaulmoogra oil and many others (see Cropwatch data-base on data-base on Threatened Aromatic SpeciesThreatened Aromatic Species).).

Media Media Bad ScienceBad Science on on Naturals – an Naturals – an

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

Bad ScienceBad Science on Naturals in on Naturals in Peer-Reviewed Journals – Peer-Reviewed Journals –

An Example.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.

Part 2. The Mis-Part 2. The Mis-regulation regulation

of Natural Ingredientsof Natural Ingredients – some Examples– some Examples

Destroying the very Destroying the very foundationsfoundations

of perfumery. of perfumery. The restriction/banning of key fragrance The restriction/banning of key fragrance ingredients on dubious / over-precautionary ingredients on dubious / over-precautionary safety grounds, can easily compromise the safety grounds, can easily compromise the founding elements of the traditional perfumery founding elements of the traditional perfumery art. For instance, the crucially important art. For instance, the crucially important fougfougèèrere perfumery accord consists of a perfumery accord consists of a combination of bergamot, coumarin & oakmoss.combination of bergamot, coumarin & oakmoss.

Bergamot oil usage is under threat from Bergamot oil usage is under threat from potential EU legislation because of its allegedly potential EU legislation because of its allegedly photo-toxic furocoumarin (FC) content (see photo-toxic furocoumarin (FC) content (see flawed flawed SCCP Opinion 0942/05, then compare SCCP Opinion 0942/05, then compare with the Cropwatch FC data-base)with the Cropwatch FC data-base)..

Oakmoss was originally proposed to be Oakmoss was originally proposed to be restricted as a sensitiser under restricted as a sensitiser under SCCP/1131/07, , limiting the potent sensitisers atranol & limiting the potent sensitisers atranol & chloroatranol to 2ppm in product. Cropwatch chloroatranol to 2ppm in product. Cropwatch (2009) described this Opinion as unsafe from a (2009) described this Opinion as unsafe from a failure to consider all the published evidence failure to consider all the published evidence (which it has subsequently made publicly (which it has subsequently made publicly available). EU pavailable). EU policy on oakmoss / treemoss has olicy on oakmoss / treemoss has since been modified.since been modified.

Public Objections to ‘Safe’ Public Objections to ‘Safe’ Reformulations of Classic Reformulations of Classic

Perfumes.Perfumes. Reformulations of classic perfumes, carried out Reformulations of classic perfumes, carried out

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

Natural Ingredient Usage Natural Ingredient Usage Declines.Declines. The usage of naturals has declined in perfumery The usage of naturals has declined in perfumery

from from downward pressure on downward pressure on ingredient costsingredient costs (synthetics are comparatively cheaper), (synthetics are comparatively cheaper), erratic erratic supplysupply (climatic & geophysical events; political (climatic & geophysical events; political events; demand pressures) & from events; demand pressures) & from stability & stability & compositional issuescompositional issues. .

Under existing EU H&S policy, natural complex Under existing EU H&S policy, natural complex substances are treated as a collection of substances are treated as a collection of individual composite chemicals. The vast individual composite chemicals. The vast majority of essential oils, absolutes & resinoids majority of essential oils, absolutes & resinoids contain several of the 26 named contain several of the 26 named allergensallergens, , which have to be labelled under EU Directive which have to be labelled under EU Directive 2003/15/EC (now under review). The desire by 2003/15/EC (now under review). The desire by cosmetic manufacturers to avoid excessive cosmetic manufacturers to avoid excessive product labelling has previously lead to some product labelling has previously lead to some decline in the overall usage of essential oils.decline in the overall usage of essential oils.

Naturals Usage Declines Naturals Usage Declines cont’d.cont’d. Under CHIP / EU DPD & DSD (now under the CLP Under CHIP / EU DPD & DSD (now under the CLP

1272/2008/EC), 1272/2008/EC), R50/53 environmental labellingR50/53 environmental labelling (dead fish / (dead fish / dead tree symbols) and dead tree symbols) and R65 labellingR65 labelling have had a serious have had a serious impact on usage of citrus oils & their terpenes. Citrus oils impact on usage of citrus oils & their terpenes. Citrus oils have been traditionally employed in many types of have been traditionally employed in many types of perfumes for household & air care products due to their perfumes for household & air care products due to their diffusion, lift & fresh character, but perfumers now find it diffusion, lift & fresh character, but perfumers now find it difficult to use them for the reasons above. Ditto for pine difficult to use them for the reasons above. Ditto for pine needle oils. needle oils.

Cinnamon leaf & clove oils were used in pot pourris & Cinnamon leaf & clove oils were used in pot pourris & candles, but candles, but R43 issuesR43 issues with cinnamic aldehyde & with cinnamic aldehyde & eugenol contents etc. mean that their use is restricted.eugenol contents etc. mean that their use is restricted.

Minor oilsMinor oils that IFRA has banned / restricted on predictive that IFRA has banned / restricted on predictive toxicological grounds, but has no funds to practically toxicological grounds, but has no funds to practically investigate – melissa, santolina, boldo etc. investigate – melissa, santolina, boldo etc. NB Cropwatch NB Cropwatch recently published the Robertet toxicological evidence on recently published the Robertet toxicological evidence on melissa oil showing the original IFRA ban was unjustifiedmelissa oil showing the original IFRA ban was unjustified

Natural products needing expert botanical identification & Natural products needing expert botanical identification & chemical analysis for chemical analysis for QRA studiesQRA studies, are/were not , are/were not supported (read: can’t afford to support) by IFRA– supported (read: can’t afford to support) by IFRA– opoponax, styrax.opoponax, styrax...

The ‘Weak Animal The ‘Weak Animal Carcinogens’ Issue.Carcinogens’ Issue. The EU classification ofThe EU classification of methyl eugenolmethyl eugenol as a as a

suspected rodent carcinogen & mutagen, and suspected rodent carcinogen & mutagen, and safrolesafrole as a hepatocarcinogen, together with as a hepatocarcinogen, together with corresponding IFRA restrictions, has led to a corresponding IFRA restrictions, has led to a great reduction in the use of those natural great reduction in the use of those natural materials which contain them, such as the materials which contain them, such as the methyl eugenol-containing spice oils: clove methyl eugenol-containing spice oils: clove bud, pimento leaf & pimento berry. The use of bud, pimento leaf & pimento berry. The use of rose oil has been similarly affected - it is now rose oil has been similarly affected - it is now virtually impossible to create a 100% natural virtually impossible to create a 100% natural rose fragrance which complies to IFRA rose fragrance which complies to IFRA guidelines, formulated with >1% rose oil. Use guidelines, formulated with >1% rose oil. Use of cinnamon leaf & nutmeg oils too, has also of cinnamon leaf & nutmeg oils too, has also been curtailed by the safrole classification, as been curtailed by the safrole classification, as has the use of basil & tarragon oils containing has the use of basil & tarragon oils containing estragole (weak carcinogen, weak mutagen)estragole (weak carcinogen, weak mutagen)..

Such limitations have had significant effects on Such limitations have had significant effects on fragrance styles entering the market place: fragrance styles entering the market place: traditional aromatic masculine fougtraditional aromatic masculine fougèères and res and rich spicy notes are very difficult to achieve at rich spicy notes are very difficult to achieve at so-called ‘safe’ levels.so-called ‘safe’ levels.  

Some Inconvenient Some Inconvenient Classifications.Classifications. SafroleSafrole: carcinogen cat. 3 mutagen cat. 2 (EFFA CoP : carcinogen cat. 3 mutagen cat. 2 (EFFA CoP

2009). Occurs in sassafras, nutmeg, mace, star anise & 2009). Occurs in sassafras, nutmeg, mace, star anise & cinnamon leaf oils.cinnamon leaf oils.

Methyl chavicolMethyl chavicol:: Possible weak genotoxic Possible weak genotoxic hepatocarcinogen (SCF 2001). Occurs in star anise, hepatocarcinogen (SCF 2001). Occurs in star anise, exotic basil, fennel, tarragon oils. exotic basil, fennel, tarragon oils.

Methyl eugenolMethyl eugenol:: Possible carcinogen (US). Calif. Prop. Possible carcinogen (US). Calif. Prop. 65 carcinogen. Occurs in rose, basil, bay WI, cananga, 65 carcinogen. Occurs in rose, basil, bay WI, cananga, citronella Sri Lanka, pimento, lovage & betel oils etc. citronella Sri Lanka, pimento, lovage & betel oils etc. Human exposure levels normally several magnitudes Human exposure levels normally several magnitudes below bioassay levels for rats, mice; relevance of rodent below bioassay levels for rats, mice; relevance of rodent data questioned (Robison & Barr 2006). data questioned (Robison & Barr 2006).

EthanolEthanol:: CMR cat 1. Cosmetic manufacturers are CMR cat 1. Cosmetic manufacturers are currently withdrawing ethanol from mouthwash currently withdrawing ethanol from mouthwash formulations. Indispensable ingredient to cosmetics formulations. Indispensable ingredient to cosmetics trade.trade.

Legislation-Compliant Legislation-Compliant Ingredients?Ingredients? Cropwatch has a large A-Z data-base of articles on the Cropwatch has a large A-Z data-base of articles on the

various various furocoumarinfurocoumarin (FC) contents of natural (FC) contents of natural products following FC phototoxicity issues (under products following FC phototoxicity issues (under SCCP/0942/05 etc.SCCP/0942/05 etc.). Companies like Treatt, Capua etc. ). Companies like Treatt, Capua etc. now market a range of FC-free citrus oils, but small now market a range of FC-free citrus oils, but small traditional producers of citrus oils are potentially traditional producers of citrus oils are potentially disadvantaged without huge technology investments. disadvantaged without huge technology investments. And for what reason? The safety case for reducing FC’ And for what reason? The safety case for reducing FC’ s to the minute levels the EU proposed in cosmetic s to the minute levels the EU proposed in cosmetic products is not robust, and other commonly used products is not robust, and other commonly used cosmetic ingredients also show photo-toxic effects. cosmetic ingredients also show photo-toxic effects.

To date, safrole-free nutmeg qualities, methyl eugenol-To date, safrole-free nutmeg qualities, methyl eugenol-free rose oil, IFRA compliant oakmoss qualities, free rose oil, IFRA compliant oakmoss qualities, furanocoumarin-free bergamot oil etc. etc. have all furanocoumarin-free bergamot oil etc. etc. have all proven to be more-easy-to-adulterate, pale olfactory proven to be more-easy-to-adulterate, pale olfactory shadows of traditionally produced natural products. shadows of traditionally produced natural products. This reduction in ingredient quality compromises the This reduction in ingredient quality compromises the art of the possible in perfumery practice.art of the possible in perfumery practice.

‘‘Allergic’ Fragrance Allergic’ Fragrance Ingredients.Ingredients. SCCNFP in Opinion SCCNFP in Opinion SCCNFP/0017/98 & 0329/00 0329/00

identified identified a number of fragrance chemicals (16 of a number of fragrance chemicals (16 of which occur in natural products) associated with a which occur in natural products) associated with a labelling obligation for allergens where conc. in the labelling obligation for allergens where conc. in the final product is <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. Council Directive 2003/15/EC. The basis for the inclusion of these chemicals as The basis for the inclusion of these chemicals as allergens has never been explained by the SCCPallergens has never been explained by the SCCP (Storrs 2007). The chairman of the SCCP (Ian White) (Storrs 2007). The chairman of the SCCP (Ian White) has co-authored a number of research papers on has co-authored a number of research papers on alleged allergens, & cannot be said to be a alleged allergens, & cannot be said to be a disinterested party.disinterested party.

Independent papers / peer-reviews (e.g. those by Independent papers / peer-reviews (e.g. those by Schnuch, Floc’h, Vocanson, several by Hostynek & Schnuch, Floc’h, Vocanson, several by Hostynek & Maibach) have indicated that there is no robust Maibach) have indicated that there is no robust clinical or experimental evidence to support many clinical or experimental evidence to support many of these 26 ingredients as allergens. of these 26 ingredients as allergens. Schnuch Schnuch (2008) asked the EU to rethink their policy. (2008) asked the EU to rethink their policy.

Hostynek & Maibach’s (2008) detailed article Hostynek & Maibach’s (2008) detailed article on on “Allergic Contact Dermatitis to Linalool: Allergen “Allergic Contact Dermatitis to Linalool: Allergen Status Disqualified” has appeared in a third Status Disqualified” has appeared in a third consecutive journal/trade magazine.consecutive journal/trade magazine.

Allergic Fragrance Allergic Fragrance Ingredients II.Ingredients II. A request for an updated scientific opinion on the A request for an updated scientific opinion on the

labelling of 26 fragrance substances which 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 made by the EU Commission of the SCCP, politically passed off as ‘a spin-off from the SCCP, politically passed off as ‘a spin-off from the public consultation (Nov 2006) on the the public consultation (Nov 2006) on the Commission proposal of regulation of some Commission proposal of regulation of some fragrance substances’.fragrance substances’.

"Scientific information of general and specific nature "Scientific information of general and specific nature has been submitted to DG-ENTR. in order to ask the has been submitted to DG-ENTR. in order to ask the SCCP for a revision of the 26 fragrances with respect SCCP for a revision of the 26 fragrances with respect to further restrictions to further restrictions and possible even delistingand 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- Cropwatch comments: if this is manifestly correct, : if this is manifestly correct, why did they go ahead with the legislation?why did they go ahead with the legislation?

Allergic Fragrance Allergic Fragrance Ingredients IIIIngredients III

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

The Tea Tree Oil (TTO) The Tea Tree Oil (TTO) DebacleDebacle TTO is in a Catch-22 situation. It is universally TTO is in a Catch-22 situation. It is universally

acknowledged by microbiologists as a useful biocide acknowledged by microbiologists as a useful biocide except by the EU Biocides Commission.except by the EU Biocides Commission. Therefore, Therefore, apparently, TTO in EU cosmetic products ‘does not have apparently, TTO in EU cosmetic products ‘does not have a cosmetic purpose’ (a cosmetic purpose’ (SCCP/1155/08).SCCP/1155/08).

Also according to SCCP/1155/08, diluted TTO might be Also according to SCCP/1155/08, diluted TTO might be unstable in cosmetic formulations, skin & eye irritation unstable in cosmetic formulations, skin & eye irritation not assessed by adequate methods. The SCCP not assessed by adequate methods. The SCCP identified data-gaps relating to subchronic toxicity, identified data-gaps relating to subchronic toxicity, percutaneous absorption, genotoxicity / carcinogenicity & percutaneous absorption, genotoxicity / carcinogenicity & reproductive toxicity. reproductive toxicity.

The ATTIA (& RIRDC) made the The ATTIA (& RIRDC) made the big mistakebig mistake of of submitting a safety dossier to the SCCP on these submitting a safety dossier to the SCCP on these shortcomings, at a cost of £200,000 Australian, thus shortcomings, at a cost of £200,000 Australian, thus creating a precedent for the whole essential oils industry. creating a precedent for the whole essential oils industry. The SCCP took nearly 2 years to evaluate their data, The SCCP took nearly 2 years to evaluate their data, and still were not satisfied. and still were not satisfied.

Adverse end-user reactions from sales of tens of millions Adverse end-user reactions from sales of tens of millions of small bottles of TTO by major distributors runs at < of small bottles of TTO by major distributors runs at < 0.0015% (Cropwatch, unpublished data).0.0015% (Cropwatch, unpublished data).

VanillinVanillin Under IFRA’s 44Under IFRA’s 44thth Amendment, vanillin was at first restricted on Amendment, vanillin was at first restricted on

alleged QRA sensitisation grounds, but this restriction is alleged QRA sensitisation grounds, but this restriction is currently suspended (this dithering costing industry hundreds currently suspended (this dithering costing industry hundreds of thousands of Euros inof thousands of Euros in reformulation, ingredient stock reformulation, ingredient stock adjustment, costs of buying in substitution stock and re-adjustment, costs of buying in substitution stock and re-labelling). Current vanillin consumption is about 6,000t/y.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).

Vanillin IIVanillin II Evidence for the alleged very weak sensitising activity of Evidence for the alleged very weak sensitising activity of

vanillin (according to IFRA) rests on 3 pieces of evidence, vanillin (according to IFRA) rests on 3 pieces of evidence, 2 of which are hardly new but are unavailable to the 2 of which are hardly new but are unavailable to the general public: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 Opposing evidence to the sensitising potential of vanillin was listed in vanillin was listed in Cropwatch Newsletter 15 Cropwatch Newsletter 15 – for – for example >99% vanillin ex lignin has been found non-example >99% vanillin ex lignin has been found non-sensitising. But it is likely that this major fragrance sensitising. But it is likely that this major fragrance ingredient will yet suffer severe usage restrictions ingredient will yet suffer severe usage restrictions on dubious QRA testing grounds.on dubious QRA testing grounds.

Coumarin ICoumarin I Coumarin is regulated by EU Directive Coumarin is regulated by EU Directive

2003/15/EC such that coumarin requires 2003/15/EC such that coumarin requires labelling as a sensitiser if present at labelling as a sensitiser if present at concentrations of >10ppm in fragranced leave- concentrations of >10ppm in fragranced leave- on products, or >100 ppm in fragranced on products, or >100 ppm in fragranced products washed off the skin. products washed off the skin.

SCCP Opinion /0935/05 on 99.9% pure coumarin, SCCP Opinion /0935/05 on 99.9% pure coumarin, shows the expert committee had misunderstood shows the expert committee had misunderstood the data, incorrectly concluding that pure the data, incorrectly concluding that pure coumarin is a coumarin is a sensitiser - Schnuch (2004), Floc’h sensitiser - Schnuch (2004), Floc’h et alet al (2002), Vocanson (2002), Vocanson et alet al (2006 & 2007) and (2006 & 2007) and many others have opposing views. Cropwatch’s many others have opposing views. Cropwatch’s submission to DG-Ent. on coumarin was never submission to DG-Ent. on coumarin was never acknowledged. acknowledged.

Minor Minor impuritiesimpurities in in somesome commercial grades of commercial grades of syntheticsynthetic coumarin used for allergy testing coumarin used for allergy testing (dihydrocoumarin; 6-chlorocoumarin etc.) (dihydrocoumarin; 6-chlorocoumarin etc.) maymay however be sensitising.however be sensitising.

Coumarin II.Coumarin II. Only 1 well-documented clinically relevant case of allergy Only 1 well-documented clinically relevant case of allergy

to coumarin has ever been reported (Mutterer to coumarin has ever been reported (Mutterer et alet al. 1999). . 1999). Low numbers of clinically relevant cases exist for many Low numbers of clinically relevant cases exist for many other alleged allergens listed under other alleged allergens listed under EU Directive EU Directive 2003/15/EC2003/15/EC. . The legislation clearly lacks proportionality.The legislation clearly lacks proportionality.

EFSA (2004) concluded that coumarin is non-genotoxic. EFSA (2004) concluded that coumarin is non-genotoxic. Any human carcinogenicity issues may only be relevant Any human carcinogenicity issues may only be relevant to very small sub-section of human population (Lake to very small sub-section of human population (Lake 1999).1999).

Federal Institute for Risk Assessment (BfR) had to be Federal Institute for Risk Assessment (BfR) had to be publicly corrected in 2007 on alleged risks with coumarin publicly corrected in 2007 on alleged risks with coumarin toxicity from cosmetics. The BfR had wrongly maintained toxicity from cosmetics. The BfR had wrongly maintained that the TDI (0.1mg/d) for coumarin could be exceeded by that the TDI (0.1mg/d) for coumarin could be exceeded by the normal application of cosmetics. Commentators are the normal application of cosmetics. Commentators are on record as saying that Prof. Hensel has, additionally, on record as saying that Prof. Hensel has, additionally, not understood species differences relevant to coumarin not understood species differences relevant to coumarin metabolism.metabolism.

Other Fragrance Other Fragrance Ingredients with Ingredients with

Questionable Restrictions.Questionable Restrictions. Benzaldehyde (used for almond & cherry notes); Benzaldehyde (used for almond & cherry notes);

tagetes oils & absolutes; oakmoss & treemoss tagetes oils & absolutes; oakmoss & treemoss qualities; FC-containing citrus oils; opoponax & qualities; FC-containing citrus oils; opoponax & styrax qualities; jasmine absolute; santolina, styrax qualities; jasmine absolute; santolina, boldo & melissa oils; oils of the Pinaceae. boldo & melissa oils; oils of the Pinaceae.

All of these and many others have been All of these and many others have been discussed by Cropwatch (see website), and discussed by Cropwatch (see website), and many are the subject on on-going investigations many are the subject on on-going investigations to reverse the hasty & over-precautionary to reverse the hasty & over-precautionary limitations imposed. limitations imposed.

References.References. Calabrese E.J. (2004) “Hormesis – basic, generalisable, central to toxicology and a method to Calabrese E.J. (2004) “Hormesis – basic, generalisable, central to toxicology and a method to

improve the risk assessment process” improve the risk assessment process” J Occup Enviro Health J Occup Enviro Health 1010(4), 466-7.(4), 466-7. Calabrese E.J. (2007) ”Belle Newsletter: Introduction. “ Calabrese E.J. (2007) ”Belle Newsletter: Introduction. “ Human & Experimental ToxicologyHuman & Experimental Toxicology

2626, 845., 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.” Durodie B. (2004) “The timid corporation – why business is terrified of taking risk.” Risk Risk

AnalysisAnalysis 2424(1), 2004.(1), 2004. EFSA (2004) EFSA (2004) Floc’h F. (2002) “Coumarin in plants and fruits: implications in perfumery.” Floc’h F. (2002) “Coumarin in plants and fruits: implications in perfumery.” Perf. & Flav.Perf. & Flav. 2727 (Mar/Apr 2002), (Mar/Apr 2002),

32-36.32-36. 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 Henley D.V., Lipson N., Korach K.S., Bloch C.A. (2007) “Prepubertal gynecomastia linked to lavender and tea tree oils.” lavender and tea tree oils.” New England Journal of MedicineNew England Journal of Medicine 356356 (5), 479–485. (5), 479–485.

Hostynek J. & Maibach H. (2008) “Allergic contact dermatitis to linalool” Hostynek J. & Maibach H. (2008) “Allergic contact dermatitis to linalool” Perfumer & Perfumer & FlavouristFlavourist 3333, 52-56., 52-56.

Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that anisyl alcohol causes allergic Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that anisyl alcohol causes allergic dermatitis?" dermatitis?" Exog. DermatolExog. Dermatol. . 22, 230-33., 230-33.

Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that amylcinnamic aldehyde causes Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that amylcinnamic aldehyde causes allergic dermatitis?" allergic dermatitis?" Exog. DermatolExog. Dermatol. . 33, 35-46., 35-46.

Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that linalool causes allergic Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that linalool causes allergic dermatitis?" dermatitis?" Exog. DermatolExog. Dermatol. . 22, 223-229., 223-229.

Hostynek J.J., Maibach H.I. (2004) “Is there evidence that geraniol causes allergic contact Hostynek J.J., Maibach H.I. (2004) “Is there evidence that geraniol causes allergic contact dermatitis?” dermatitis?” Exog. Dermatol.Exog. Dermatol. 33(6), 318-331. (6), 318-331.

Hostynek J.J., Maibach H.I. (2004) “Sensitisaton potential of citronellol” Hostynek J.J., Maibach H.I. (2004) “Sensitisaton potential of citronellol” ExogExog DermatolDermatol 33(6), (6), 307-312.307-312.

Hostynek J.J., Maibach H.I. (2004) “Is there evidence that alpha-methyl-ionone causes Hostynek J.J., Maibach H.I. (2004) “Is there evidence that alpha-methyl-ionone causes allergic contact dermatitis?” allergic contact dermatitis?” Exog. DermatolExog. Dermatol. . 33(3), 121-143. (3), 121-143.

Hostynek J.J., Maibach H.I. (2006) “Is there evidence that alpha-methyl-ionone causes Hostynek J.J., Maibach H.I. (2006) “Is there evidence that alpha-methyl-ionone causes allergic contact dermatitis?” allergic contact dermatitis?” Cutaneous & Ocular ToxicolCutaneous & Ocular Toxicol. . 2525(4), 259-271(4), 259-271

Hunt B. (2004) The Timid Corporation – Why Business is Terrified of Taking Risk

References cont’d.References cont’d. Lake B.G. (1999) “"Coumarin metabolism, toxicity & carcinogenicity: Lake B.G. (1999) “"Coumarin metabolism, toxicity & carcinogenicity:

relevance for human risk assessment" relevance for human risk assessment" Food and Chemical ToxicologyFood and Chemical Toxicology 37, 37, 423-453423-453

Lawrence B.M. (2007) “Estrogenic activity of lavender & tea tree oils Part Lawrence B.M. (2007) “Estrogenic activity of lavender & tea tree oils Part II.” II.” Perf. & FlavPerf. & Flav June 2007. June 2007.

Mutterer V., Giménez Arnau E., Lepoittevin J.P., Johansen J.D., Frosch P.J., 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) 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 "Identification of coumarin as the sensitizer in a patient sensitive to her own perfume but negative to the fragrance mix." perfume but negative to the fragrance mix." Contact Dermatitis.Contact Dermatitis. 4040(4):196-9. (4):196-9.

Nielsen J.B. (2008) “What you see may not always be what you get – Nielsen J.B. (2008) “What you see may not always be what you get – Bioavailability and extrapolation from in vitro tests.” Bioavailability and extrapolation from in vitro tests.” Toxicology in Vitro Toxicology in Vitro

Newman N. (2002) "Big Pharma, bad science." Newman N. (2002) "Big Pharma, bad science." TheThe NationNation 25 July 2002. 25 July 2002. Robison S.H. & Barr D.B. “Use of biomonitoring data to evaluate methyl Robison S.H. & Barr D.B. “Use of biomonitoring data to evaluate methyl

eugenol exposure.” eugenol exposure.” Environ Health PerspectEnviron Health Perspect. . 114114(11), 1797-18001.(11), 1797-18001. Schnuch A. Schnuch A. (2004) (2004) Öko-TestÖko-Test, No. , No. 77 (July) 2004, 55 (July) 2004, 55 Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) “Sensitization Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) “Sensitization

to 26 fragrances to be labelled according to current European regulation. to 26 fragrances to be labelled according to current European regulation. Results of the IVDK and review of the literature.” Results of the IVDK and review of the literature.” Contact Dermatitis.Contact Dermatitis. 5757(1),1-10.(1),1-10.

Shenck G.O. (1979) Shenck G.O. (1979) Perf KosmPerf Kosm 6060, 397., 397. Storrs F.J. (2007) “Allergen of the year: fragrance.” Storrs F.J. (2007) “Allergen of the year: fragrance.” DermatitisDermatitis 1818(1),3-7(1),3-7 Turin L. (2007) “Due Credit”Turin L. (2007) “Due Credit” NZZ Folio NZZ Folio 04/0704/07.. Vocanson M. (2006). "The skin allergenic properties of chemicals may "The skin allergenic properties of chemicals may

depend on contaminants – Evidence from studies on coumarin." depend on contaminants – Evidence from studies on coumarin." Int Arch Int Arch Allergy ImmunolAllergy Immunol 140140, 231–238 , 231–238

Vocanson M. Vocanson M. et al.et al. (2007) “ (2007) “Lack of evidence for allergenic properties of Lack of evidence for allergenic properties of coumarin in a fragrance allergy mouse model.” coumarin in a fragrance allergy mouse model.” Contact DermatitisContact Dermatitis 5757(6), (6), 361-364.361-364.

Acronyms.Acronyms. ATTIA – Australian Tea Tree Industries AssociationATTIA – Australian Tea Tree Industries Association BfR - Federal Institute for Risk Assessment BfR - Federal Institute for Risk Assessment BPD – Biocidal Products Directive BPD – Biocidal Products Directive DG-ENT - DG-ENT - Directorate General (Branch of European Commission Directorate General (Branch of European Commission

responsible for Industry) responsible for Industry) CoP – Code of PracticeCoP – Code of Practice E.O. – Essential OilE.O. – Essential Oil ECHA - European Flavour & Fragrance AssociationECHA - European Flavour & Fragrance Association EFSA - European Flavour & Fragrance AssociationEFSA - European Flavour & Fragrance Association FC – FuroCoumarinFC – FuroCoumarin H&S – Health & SafetyH&S – Health & Safety IFRA - International Fragrance AssociationIFRA - International Fragrance Association QRA - Quantitative Risk AssessmentQRA - Quantitative Risk Assessment REACH - Registration, Evaluation, Authorisation and Restriction of REACH - Registration, Evaluation, Authorisation and Restriction of

ChemicalsChemicals RIFM - Research Institute for Fragrance MaterialsRIFM - Research Institute for Fragrance Materials RIRDC – Rural Industries Research & Development Corporation RIRDC – Rural Industries Research & Development Corporation

(Australian Govt).(Australian Govt). SCCNFP - SCCNFP - Scientific Committee on Cosmetic Products and Non-Food Scientific Committee on Cosmetic Products and Non-Food

ProductsProducts SCCP - Scientific Committee on Consumer ProductsSCCP - Scientific Committee on Consumer Products SCF – Scientific Committee on FoodSCF – Scientific Committee on Food SME – Small to Medium sized EnterpriseSME – Small to Medium sized Enterprise TDI - Tolerable Daily IntakeTDI - Tolerable Daily Intake TTO – Tea Tree OilTTO – Tea Tree Oil VOC – volatile organic carbonsVOC – volatile organic carbons