Presentation on theme: ""Is excessive regulation destroying the perfumery art?" by Tony Burfield Cropwatchwww.cropwatch.org."— Presentation transcript:
"Is excessive regulation destroying the perfumery art?" by Tony Burfield Cropwatchwww.cropwatch.org
Logo: Juniperus procera Hochst. ex Endl. (Kenyan Cedarwood): Over-Exploited to Near Extinction by the E.O. Trade.
Who are Cropwatch? A loosely based, non-financed, independent watch- dog to the aroma & natural products trade. In existence approx 6-7 years. Best known for its pro-active campaigning activities on natural aromatics, data-bases on threatened aromatic species & bio-piracy, long-term opposition to the 26 allergens legislation, & to the QRA (which the SCCP has also criticised in. Best known for its pro-active campaigning activities on natural aromatics, data-bases on threatened aromatic species & bio-piracy, long-term opposition to the 26 allergens legislation, & to the QRA (which the SCCP has also criticised in SCCP/1153/08). No formal membership; produces an occasional Cropwatch Newsletter which reaches some 40,000 people. Provides free information on natural aromatics on its website www.cropwatch.org and free advice to enquirers. www.cropwatch.org
Part I – Perceived Problems with Fragrance Safety Legislation & Safety ‘Experts’.
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).
Safety Issues in the Aroma Business cont’d. Safety Issues in the Aroma Business cont’d. 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 - & -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 ( Crop of Unregulated Allyl Isocyanate & Benzyl Cyanide Emitters (Brassica napus L. ssp. oleifera).
Forest of Unregulated - & -Pinene Emitters (Pinus sp.), Finland, near Local Aquifer! (can you spot the Daphnia?)
Unregulated Phenylacetaldehyde Emitters Lotus corniculatus L. growing in the Shetlands!
Unregulated Plateful of Suspected Rodent Carcinogen posing as Foodstuff.
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 (. 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 re- located 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.
Part 2. The Mis-regulation of Natural Ingredients – some Examples
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, 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. 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.
Naturals Usage Declines cont’d. 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. 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 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 < 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. 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’h, 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’s (2008) detailed article on “Allergic Contact Dermatitis to Linalool: Allergen Status Disqualified” has appeared in a third consecutive journal/trade magazine.
Allergic Fragrance Ingredients II. A request for an updated scientific opinion on the labelling of 26 fragrance substances which 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’. 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? - Cropwatch comments: if this is manifestly correct, why did they go ahead with the legislation?
Allergic Fragrance Ingredients III 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 44 th 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).
Vanillin II 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 I 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.
Coumarin II. 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. 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
References cont’d. 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. 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. "The skin allergenic properties of chemicals may depend on contaminants – Evidence from studies on coumarin." Int Arch Allergy Immunol 140, 231–238 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