"Legislators & Natural "Legislators & Natural Aromatics: A Modern Aromatics: A Modern

Day Vendetta."Day Vendetta."

Tony Burfield, Cropwatch Tony Burfield, Cropwatch to SCS Symposium, to SCS Symposium,

Grantham UK, May 2009Grantham UK, May 2009

About Cropwatch….About Cropwatch….Cropwatch is an Independent Watchdog for Cropwatch is an Independent Watchdog for Natural Aromatic Products Natural Aromatic Products used within the used within the cosmetic, flavour, pharmaceutical, natural cosmetic, flavour, pharmaceutical, natural biocide, essential oil supply & aromatherapy biocide, essential oil supply & aromatherapy industries. Core concerns include the over-industries. Core concerns include the over-exploitationexploitation ofof rare & threatenedrare & threatened aromatic plantsaromatic plants in the wild, and pro-active campaigning against in the wild, and pro-active campaigning against misappropriate regulation & codes of practice misappropriate regulation & codes of practice purported by the various legislatory bodies & purported by the various legislatory bodies & trade-funded associations. trade-funded associations.

Cropwatch is approx 6 years old; UK-based; Cropwatch is approx 6 years old; UK-based; non-financed; no formal membership; supporters non-financed; no formal membership; supporters contribute to & receive occasional contribute to & receive occasional CropwatchCropwatch NewslettersNewsletters. Cropwatch offers free technical . Cropwatch offers free technical articles & extensive data-bases on its website.articles & extensive data-bases on its website.

Cropwatch sets the sceneCropwatch sets the sceneFreedom of choice (to buy products containing natural Freedom of choice (to buy products containing natural ingredients) has been forensically removed from the public via ingredients) has been forensically removed from the public via the progressive actions of various over-precautious* safety the progressive actions of various over-precautious* safety regulators within the EU, US & Canada. Officials rely on regulators within the EU, US & Canada. Officials rely on ‘expert’ scientific opinion - which often defers to an existing ‘expert’ scientific opinion - which often defers to an existing culture of toxicological imperialism & corporate science culture of toxicological imperialism & corporate science resulting in over-precautious, overly complex legislation. An resulting in over-precautious, overly complex legislation. An example of this is the EU biocides legislation, which example of this is the EU biocides legislation, which discriminates politically & economically against natural discriminates politically & economically against natural products & the SME’s marketing them.products & the SME’s marketing them.

Industry does little to contest the validity of much of the poor & Industry does little to contest the validity of much of the poor & incomplete science behind the progressive over-regulation & incomplete science behind the progressive over-regulation & restriction of natural ingredients. It is evidently more restriction of natural ingredients. It is evidently more concerned with adhering to the existing hyper- bureaucratic concerned with adhering to the existing hyper- bureaucratic system, than challenging it. system, than challenging it.

* i.e. * i.e. not not having scientific certainty is having scientific certainty is not not a justification for a justification for notnot regulating - through Hanekamp & Bast (2007).regulating - through Hanekamp & Bast (2007).

Natural biocides excluded from public useNatural biocides excluded from public use..The heavily criticised Biocidal Products Directive (BPD) The heavily criticised Biocidal Products Directive (BPD) 98/8/EC, effective 2000, was drawn up via advice from 98/8/EC, effective 2000, was drawn up via advice from synthetic biocides industry experts, & failed to exclude (read: synthetic biocides industry experts, & failed to exclude (read: protect) the low-toxicity substances for which it was designed protect) the low-toxicity substances for which it was designed (like essential oils & pheromones). (like essential oils & pheromones). Some 50-odd initially notified essential oils under the BPD Some 50-odd initially notified essential oils under the BPD (citronella, geranium, lavender etc) were unable to be (citronella, geranium, lavender etc) were unable to be supported by SME’s on cost grounds: estimated at 14,000 to supported by SME’s on cost grounds: estimated at 14,000 to 183,000 Euros / substance (see impact report on the BPD 183,000 Euros / substance (see impact report on the BPD commissioned for DG-Environment, completed 2005 (and 5 commissioned for DG-Environment, completed 2005 (and 5 years too late for the SME’s with relevant interests). years too late for the SME’s with relevant interests). Following the impact assessment, a time extension for Following the impact assessment, a time extension for essential oils (as ‘undefended substances’) was granted essential oils (as ‘undefended substances’) was granted under EC Reguln. No 1048/2005, but under EC Reguln. No 1048/2005, but only for the supporting only for the supporting registrantregistrant. The 2. The 2ndnd phase of the BPD under article 16(2) phase of the BPD under article 16(2) carried forward under 1451/2007/EC will not change the carried forward under 1451/2007/EC will not change the situation for niche products marketed by SME’s with sparse situation for niche products marketed by SME’s with sparse economic resources.economic resources.The Biocides Commission cannot say they did not understand The Biocides Commission cannot say they did not understand the quandary for the natural biocides sector. Their present the quandary for the natural biocides sector. Their present market exclusion can only be viewed as exactly the outcome market exclusion can only be viewed as exactly the outcome that the synthetic biocides industry had planned.that the synthetic biocides industry had planned.

Destroying the cultural inheritance & art Destroying the cultural inheritance & art of perfumery.of perfumery.

The restriction/banning of key fragrance ingredients The restriction/banning of key fragrance ingredients on dubious or over-precautionary safety grounds, on dubious or over-precautionary safety grounds, can easily compromise the founding elements of the can easily compromise the founding elements of the traditional perfumery art. For instance, the crucially traditional perfumery art. For instance, the crucially important important fougfougèèrere accord consists of a combination accord consists of a combination of bergamot, coumarin & oakmoss.of bergamot, coumarin & oakmoss.Bergamot oil usage is under threat from EU Bergamot oil usage is under threat from EU legislation because of its photo-toxic legislation because of its photo-toxic furanocoumarin (FC) content (see flawed furanocoumarin (FC) content (see flawed SCCP SCCP Opinion 0942/05)Opinion 0942/05)..Coumarin is an alleged sensitiser under Coumarin is an alleged sensitiser under SCCP/0935/05, and is recently restricted by IFRASCCP/0935/05, and is recently restricted by IFRA..Oakmoss is proposed to be restricted as a sensitiser Oakmoss is proposed to be restricted as a sensitiser under under SCCP/1131/07, which , which limits the contained limits the contained potent sensitisers atranol & chloroatranol to 2ppm in potent sensitisers atranol & chloroatranol to 2ppm in product.product. But theBut the sensitisingsensitising potency of atranol & potency of atranol & chloroatranol is now under acrimonious dispute.chloroatranol is now under acrimonious dispute.

Why are natural ingredients so important to Why are natural ingredients so important to fragrances?fragrances?

Naturals Naturals breathe life into an otherwise simple blend of breathe life into an otherwise simple blend of chemicals. They add depth and sophistication-whether it chemicals. They add depth and sophistication-whether it is floral absolutes, woody materials or citrus oils that are is floral absolutes, woody materials or citrus oils that are employed.employed.Whole fragrance styles/families would not exist without Whole fragrance styles/families would not exist without naturals – for example, Eau de Colognes.naturals – for example, Eau de Colognes.Many landmark fragrances & fragrance styles owe their Many landmark fragrances & fragrance styles owe their conception to key natural materials e.g. the conception to key natural materials e.g. the chyprechypre style style of of MitsoukoMitsouko & & Miss DiorMiss Dior, which were based on accords , which were based on accords of oakmoss, patchouli oil and labdanum together with of oakmoss, 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 & petitgrain. freshness to fragrances e.g. lime, lavender & petitgrain. It is hard to imagine a masculine fine fragrance which It is hard to imagine a masculine fine fragrance which merely relied only on synthetic materials for its merely relied only on synthetic materials for its freshness. For example, accords of linalyl acetate, freshness. For example, accords of linalyl acetate, dihydromycenol & allyl amyl glycollate, with no bergamot, dihydromycenol & allyl amyl glycollate, with no bergamot, lemon, lavender or rosemary oils, would belemon, lavender or rosemary oils, would be perceived as perceived as flat, lifeless & chemical.flat, lifeless & chemical.

The decline of naturals in perfumeryThe decline of naturals in perfumeryThe usage of naturals has declined in perfumery from The usage of naturals has declined in perfumery from downward pressure on downward pressure on ingredient costsingredient costs (synthetics are (synthetics are comparatively cheaper), comparatively cheaper), erratic supplyerratic supply (weather; political (weather; political events; demand pressures) & from events; demand pressures) & from stability issuesstability issues. .

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

IFRA ban on IFRA ban on benzyl cyanidebenzyl cyanide & its movement into Annex & its movement into Annex III of Cosmetic DirectiveIII of Cosmetic Directive has virtually stopped the use of has virtually stopped the use of karo karunde in perfumery, and also impacts on karo karunde in perfumery, and also impacts on tuberose, orange flower absolute & jasmine usage in tuberose, orange flower absolute & jasmine usage in natural perfumery. natural perfumery.

   

The decline of naturals in perfumery - IIThe decline of naturals in perfumery - II

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

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

The decline of naturals in perfumery - IIIThe decline of naturals in perfumery - IIIUnder CHIP/EU DPD (now under 1272/2008/EC), Under CHIP/EU DPD (now under 1272/2008/EC), R50/53 environmental labelling (dead fish/tree symbols) R50/53 environmental labelling (dead fish/tree symbols) and R65 labelling have had a serious impact on usage of and R65 labelling have had a serious impact on usage of citrus oils & their terpenes. Citrus oils have been citrus oils & their terpenes. Citrus oils have been traditionally employed in many types of perfumes for traditionally employed in many types of perfumes for household & air care products due to their diffusion, lift & household & air care products due to their diffusion, lift & fresh character, but perfumers now find it difficult to use fresh character, but perfumers now find it difficult to use them for the reasons above. Ditto for pine needle oils. them for the reasons above. Ditto for pine needle oils. Cinnamon leaf & clove oils were used in pot pourris & Cinnamon leaf & clove oils were used in pot pourris & candles, but R43 issues with cinnamic aldehyde & candles, but R43 issues with cinnamic aldehyde & eugenol contents etc. mean that their use is restricted.eugenol contents etc. mean that their use is restricted.Minor oils that IFRA has banned on predictive Minor oils that IFRA has banned 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. Natural products needing expert botanical identification & Natural products needing expert botanical identification & chemical analysis for QRA studies, that IFRA can no chemical analysis for QRA studies, that IFRA can no longer support (read: can’t afford)– opoponax, styrax. longer support (read: can’t afford)– opoponax, styrax. Styrax resinoids & essential oils, were once important Styrax resinoids & essential oils, were once important perfumery ingredients. perfumery ingredients.

QuoteQuote

“ “Today, great perfumery is seriously Today, great perfumery is seriously hampered by regulators, who confuse hampered by regulators, who confuse hazard with risk.”hazard with risk.”

- Lambert Dekker, TakasagoLambert Dekker, Takasago Perfumer & FlavoristPerfumer & Flavorist (2008) (2008) 3333(9), 28.(9), 28.

The media seizes on (virtually any) bad The media seizes on (virtually any) bad news about natural products.news about natural products.

Gynecomastia in 3 pre-pubertal boys, allegedly Gynecomastia in 3 pre-pubertal boys, allegedly caused by lavender/TTO-containing caused by lavender/TTO-containing cosmetics/personal care products (Henley cosmetics/personal care products (Henley et alet al. . 2007), received much media (newspaper) 2007), received much media (newspaper) coverage. The coverage. 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 it could not find independent a policy change, as it could not find independent experts for reviews, who had not been paid off in experts for reviews, who had not been paid off in some way by industry (Newman 2002). A pity, some way by industry (Newman 2002). A pity, because refutation of the robustness of the because refutation of the robustness of the alleged gynecomastia-lavender/TTO link alleged gynecomastia-lavender/TTO link followed (e.g. by Nielson 2008 & Lawrence 2007 followed (e.g. by Nielson 2008 & Lawrence 2007 amongst others), but of course, hardly received amongst others), but of course, hardly received any attention from the popular media.any attention from the popular media.

Customers object to reformulations of Customers object to reformulations of classic perfumes.classic perfumes.

Reformulations of classic perfumes, carried out in order Reformulations of classic perfumes, carried out in order that they conform to modern regulatory requirements, that they conform to modern regulatory requirements, have led to disappointment and bitterness amongst their have led to disappointment and bitterness amongst their long-term devotees, whose historical memories and long-term devotees, whose historical memories and emotional attachments are evoked by the odour profiles emotional attachments are evoked by the odour profiles of particular fragrances, as part of their rightful cultural of particular fragrances, as part of their rightful cultural inheritance. Many fragrance houses seem in-denial inheritance. Many fragrance houses seem in-denial about the whole subject, but Turin (2007) has remarked about the whole subject, but Turin (2007) has remarked on customer anger generated during the Guerlain on customer anger generated during the Guerlain MitsoukoMitsouko reformulation debacle. Internet discussions on reformulation debacle. Internet discussions on a wider range of classic perfumes whose character has a wider range of classic perfumes whose character has been allegedly mutilated by reformulation are available been allegedly mutilated by reformulation are available (for example see (for example see Perfume of Life Forum Perfume of Life Forum Jan 2007)…Jan 2007)…Cultural inheritance rights (see above) over & above Cultural inheritance rights (see above) over & above safety issues have been granted by the EU Commission safety issues have been granted by the EU Commission in other areas – so why not in perfumery?in other areas – so why not in perfumery?

Over-regulation.Over-regulation. Essential oils need to conform to / are regulated by/ are Essential oils need to conform to / are regulated by/ are

restricted by:restricted by:

National Pharmacopoeias, ISO Stds, EOA Stds, IFRA Stds, National Pharmacopoeias, ISO Stds, EOA Stds, IFRA Stds, EFFA CoP’s, FEMA/GRAS, EU Cosm. DirectiveEFFA CoP’s, FEMA/GRAS, EU Cosm. DirectiveIf Biocides, under 98/8/EC. If Cosmetics 76/768/EEC. If Biocides, under 98/8/EC. If Cosmetics 76/768/EEC. If flavourings, under 88/388/EEC & 199/217/EC, if If flavourings, under 88/388/EEC & 199/217/EC, if food/feedstuffs 178/2002/ EC. food/feedstuffs 178/2002/ EC. If Allergic data, to Directive 2003/15/EC If Allergic data, to Directive 2003/15/EC If Medicinal Products 2001/83/EC; Trad. Meds 24/2004/EC;If Medicinal Products 2001/83/EC; Trad. Meds 24/2004/EC;

Vetinary Medicinal products under 2001/82/EC Vetinary Medicinal products under 2001/82/EC GMO declarations under EC 1829/2003 & EC 1830/2003 GMO declarations under EC 1829/2003 & EC 1830/2003 Limits on heavy metals, dioxins, PCB’s, pesticides, 3-MCPD Limits on heavy metals, dioxins, PCB’s, pesticides, 3-MCPD etc under 88/388/EEC if flavourings; also not allowed to be etc under 88/388/EEC if flavourings; also not allowed to be present under 76/768/EEC.present under 76/768/EEC.Labelling & packaging regulations, transporting & shipping Labelling & packaging regulations, transporting & shipping regulations. (CHIP; regulations. (CHIP; Classification Packaging / Labelling Classification Packaging / Labelling Directive 1272/2008/EC replacing 1999/4/EC & 1907/2006) Directive 1272/2008/EC replacing 1999/4/EC & 1907/2006) REACH 1907/2006/ECREACH 1907/2006/EC

Legislation-compliant ingredientsLegislation-compliant ingredients – a new opportunity – a new opportunity

Cropwatch has a large A-Z data-base of articles Cropwatch has a large A-Z data-base of articles available (in the available (in the Cropwatch FilesCropwatch Files on its website) listing on its website) listing the various furanocoumarin (FC) contents of natural the various furanocoumarin (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 technological investment. disadvantaged without huge technological investment. And for what reason? The safety case for reducing FC’ s And for what reason? The safety case for reducing FC’ s to the minute levels the EU proposed in cosmetic 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. This shadows of traditionally produced natural products. This reduction in ingredient quality compromises the art of the reduction in ingredient quality compromises the art of the possible in perfumery practice.possible in perfumery practice.

Compare & Contrast: Pharmaceuticals and Compare & Contrast: Pharmaceuticals and Cosmetics.Cosmetics.

Laurance J. (2003) “Reactions to common medicines kill Laurance J. (2003) “Reactions to common medicines kill 10,000 each year.” 10,000 each year.” Independent Independent Fri 2 July 2004 p8. Fri 2 July 2004 p8.

Vioxx (a drug marketed by Merk used to control blood Vioxx (a drug marketed by Merk used to control blood pressure) has killed between 88,000 and 119,00 patients. pressure) has killed between 88,000 and 119,00 patients. LancetLancet 365(9458), 475–81 (2005). 365(9458), 475–81 (2005).

No reported deaths from application of cosmetics in EU No reported deaths from application of cosmetics in EU in 2008. Or in 2007, or in 2006… Some concern over lead in 2008. Or in 2007, or in 2006… Some concern over lead ingredients in eye cosmetics from Pakistan (2009) and ingredients in eye cosmetics from Pakistan (2009) and lead levels in lipstick generally (disputed: 2008)…but no lead levels in lipstick generally (disputed: 2008)…but no fatalities reported in the literature. N.B. lead products are fatalities reported in the literature. N.B. lead products are still allowed in hair dyes in EU.still allowed in hair dyes in EU.

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). Similar low numbers of clinically relevant cases for many Similar low numbers of clinically relevant cases 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.

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

The EU Cosmetics Commissions’ CoP does not The EU Cosmetics Commissions’ CoP does not offer a definition of safety, does not quantify offer a definition of safety, does not quantify individual ingredient risks, individual ingredient risks, does not allow does not allow ingredient risk/benefit considerationsingredient risk/benefit considerations, does not , does not allow in-use considerations, & does not allow for allow in-use considerations, & does not allow for consumer adverse reactions consumer adverse reactions (or lack of them)(or lack of them) to to affect safety policy. affect safety policy. This ‘risk-only’ scenario leads to the situation of This ‘risk-only’ scenario leads to the situation of toxicological imperialism, where over-precaution toxicological imperialism, where over-precaution & scare-mongering predominate, and where & scare-mongering predominate, and where pharmaceutical & chemical company lobbying pharmaceutical & chemical company lobbying disadvantage competitive natural products. disadvantage competitive natural products. Worrying situations of vested interest (e.g. Worrying situations of vested interest (e.g. individual SCCP members acting as witness, individual SCCP members acting as witness, judge & jury over issues like oakmoss & judge & jury over issues like oakmoss & treemoss sensitisation), remain unaddressed. treemoss sensitisation), remain unaddressed.

HormesisHormesis EU Cosm. Comm. imported an outline scheme for the Cosmetics EU Cosm. Comm. imported an outline scheme for the Cosmetics Directive 76/768/EC already in existence for food & pharmaceutical Directive 76/768/EC already in existence for food & pharmaceutical legislation - use of known risks associated with single ingredients, legislation - use of known risks associated with single ingredients, creation of (negative) lists etc. It is firmly based on the creation of (negative) lists etc. It is firmly based on the Precautionary PrinciplePrecautionary Principle, itself the subject of intense dispute over the , itself the subject of intense dispute over the last 20 years wrt. its exact formulation & manner of application. last 20 years wrt. its exact formulation & manner of application. The idea that toxic effects of chemical show a dose-dependent The idea that toxic effects of chemical show a dose-dependent linear relationship ending at a threshold level is now challenged: at linear relationship ending at a threshold level is now challenged: at low levels adaptive, non-adverse or even beneficial effects occur low levels adaptive, non-adverse or even beneficial effects occur ((hormesishormesis), and have been shown for >6,000 chemicals (Calabrese ), and have been shown for >6,000 chemicals (Calabrese 2004). 2004). This raises a ‘serious misreading of the term toxic’ charge for the This raises a ‘serious misreading of the term toxic’ charge for the EPA, and the ECHA over the REACH legislation, and suggests that EPA, and the ECHA over the REACH legislation, and suggests that the 50-100 million Euros spent on the exercise is wasted, and will the 50-100 million Euros spent on the exercise is wasted, and will not save a single life. not save a single life. The above reference to the EPA needs to be seen as what appears The above reference to the EPA needs to be seen as what appears to be to be a gagging ordera gagging order, mentioned a document prepared by the EPA , mentioned a document prepared by the EPA in 2004, which states that the purpose of a risk assessment is to in 2004, which states that the purpose of a risk assessment is to identify risk (harm, adverse effect etc.), identify risk (harm, adverse effect etc.), effects that appear to be effects that appear to be adaptive, non-adverse or beneficial may not be mentioned.adaptive, non-adverse or beneficial may not be mentioned.

- Through Calabrese (2007) ”Belle Newsletter: Introduction. “ - Through Calabrese (2007) ”Belle Newsletter: Introduction. “ Human & Experimental ToxicologyHuman & Experimental Toxicology 2626, 845., 845.

Hormesis – cont’d.Hormesis – cont’d.Proponents of the hormetic model are far from unworldly, Proponents of the hormetic model are far from unworldly, and predictand predict that industry will resist the hypothesis that industry will resist the hypothesis (Hanekamp & Bast 2007). Earlier, Calabrese (2004) had (Hanekamp & Bast 2007). Earlier, Calabrese (2004) had stated “stated “Of course, a protectionist philosophy dominated Of course, a protectionist philosophy dominated by a linear dose-response model and obsessed with by a linear dose-response model and obsessed with achieving zero risk will have difficulties accepting this achieving zero risk will have difficulties accepting this notion“; and again “If only zero risk is acceptable to the notion“; and again “If only zero risk is acceptable to the public, then it is easy to call for the complete public, then it is easy to call for the complete abolishment of a product or activity that carries with it abolishment of a product or activity that carries with it some risk, no matter how large the costs or benefits.” some risk, no matter how large the costs or benefits.”

Cropwatch, too, imagines the corporate science-career Cropwatch, too, imagines the corporate science-career toxicologist-regulatory lawyer alliance will resist the toxicologist-regulatory lawyer alliance will resist the acceptance of the hormetic hypothesis. Perhaps acceptance of the hormetic hypothesis. Perhaps Jostman sums it up best (Jostman 2007): “Absolute Jostman sums it up best (Jostman 2007): “Absolute reassurance & ‘no risk’ policy is, however, contributing to reassurance & ‘no risk’ policy is, however, contributing to the risk adversity of our society and triggers biased the risk adversity of our society and triggers biased regulation, which will not deliver substantial regulation, which will not deliver substantial environmental or health benefit.” environmental or health benefit.”

Cropwatch despairs of ‘the experts’Cropwatch despairs of ‘the experts’ Many experimental safety studies have been carried out Many experimental safety studies have been carried out on plant extracts/distillates from plants which were on plant extracts/distillates from plants which were not not expertly botanically identified at sourceexpertly botanically identified at source, were not batch-, were not batch-tracked & not tested as being 100% derived from the tracked & not tested as being 100% derived from the named botanical (i.e. named botanical (i.e. may well be adulteratedmay well be adulterated). Individual ). Individual chemical constituents used in studies have often been chemical constituents used in studies have often been impure syntheticsimpure synthetics purchased from companies such as purchased from companies such as Fluka, Sigma-Aldrich or Extrasynthese, rather than Fluka, Sigma-Aldrich or Extrasynthese, rather than 99.99%+ authentic components worked up from the 99.99%+ authentic components worked up from the natural source. natural source. Recommendations on safety are made by ‘expert Recommendations on safety are made by ‘expert committees’ populated by academics with no industrial committees’ populated by academics with no industrial experience, which lack cross-disciplinary skills, & cannot experience, which lack cross-disciplinary skills, & cannot foresee the consequences of their actions. Staff from the foresee the consequences of their actions. Staff from the EU Comm. have previously admitted that the SCCP lack EU Comm. have previously admitted that the SCCP lack botanical expertise & botanical expertise & only had access to independent only had access to independent literature searching in 2007 for their Opinion-forming literature searching in 2007 for their Opinion-forming duties duties (!)(!).. Now a pool of 160 ‘experts’ is to be made Now a pool of 160 ‘experts’ is to be made available to Brussels staff….available to Brussels staff….

Tea tree oil (TTO)Tea tree oil (TTO)TTO is added to cosmetics for its known beneficial TTO is added to cosmetics for its known beneficial properties (anti-inflammatory, biocidal etc.) & not for any properties (anti-inflammatory, biocidal etc.) & not for any other reason. But the EU does not accept risk/benefit other reason. But the EU does not accept risk/benefit scenarios in health & safety assessments (“Opinions”) scenarios in health & safety assessments (“Opinions”) carried out by the SCCP. carried out by the SCCP. (Almost) no-one is investigating the (Almost) no-one is investigating the medical/pharmacological properties of TTO, because the medical/pharmacological properties of TTO, because the pharmaceutical industry is unable to profit from natural pharmaceutical industry is unable to profit from natural products, by issuing patents etc. products, by issuing patents etc. So, in spite of 80 years of safe use of TTO, the So, in spite of 80 years of safe use of TTO, the pharmaceutical/chemical industry could theoretically find pharmaceutical/chemical industry could theoretically find a way to lobby Brussels, alleging stability & sensitisation a way to lobby Brussels, alleging stability & sensitisation problems, and hope to remove TTO as a competitive problems, and hope to remove TTO as a competitive product… but of course this would never be allowed to product… but of course this would never be allowed to happen ….happen ….

Tea tree oil gets a bad rap…Tea tree oil gets a bad rap…Common sense tells us that tea tree oil is no more Common sense tells us that tea tree oil is no more unstable or more unsafe than a large number of unstable or more unsafe than a large number of other commonly used essential oils, but…. other commonly used essential oils, but…. In SCCP Opinion In SCCP Opinion SCCP/0834/04: undiluted TTO used SCCP/0834/04: undiluted TTO used for a cosmetic purpose might not be safe for a cosmetic purpose might not be safe (cosmetic (cosmetic purpose questioned in SCCP/1155/08)purpose questioned in SCCP/1155/08), diluted TTO , diluted TTO might be unstable in cosmetic formulations, skin & might be unstable in cosmetic formulations, skin & eye irritation not assessed by adequate methods. eye irritation not assessed by adequate methods. SCCP identified data-gaps relating to subchronic SCCP identified data-gaps relating to subchronic toxicity, percutaneous absorption, toxicity, percutaneous absorption, genotoxicity/carcinogenicity & reproductive toxicity. genotoxicity/carcinogenicity & 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 creating a precedent for the whole essential oils industry. The SCCP took nearly 2 years to evaluate industry. The SCCP took nearly 2 years to evaluate their data, and were still not satisfied.their data, and were still not satisfied.

Tea Tree Oil Industry Destabilised.Tea Tree Oil Industry Destabilised.Meanwhile the SCCP’s critical questioning about tea tree Meanwhile the SCCP’s critical questioning about tea tree oil safety destabilised & unsettled the Australian TTO oil safety destabilised & unsettled the Australian TTO industry, plantations closed & the TTO price/Kg rose. industry, plantations closed & the TTO price/Kg rose. This situation let in competition from Chinese TTO, often This situation let in competition from Chinese TTO, often inferior in quality & different in composition.inferior in quality & different in composition.The BfR joined in the scare-mongering. In a statement The BfR joined in the scare-mongering. In a statement dated 1dated 1stst Sept 2003, they declared 100% TTO used for a Sept 2003, they declared 100% TTO used for a cosmetic purpose cosmetic purpose (what cosmetic purpose?)(what cosmetic purpose?) as unsafe & as unsafe & recommended a 1% concentration limit in cosmetics – a recommended a 1% concentration limit in cosmetics – a concentration at which they doubt TTO would have a concentration at which they doubt TTO would have a pharmacological effect. COLIPA (2002) similarly pharmacological effect. COLIPA (2002) similarly suggested a 1% conc. limit in cosmetics, but then suggested a 1% conc. limit in cosmetics, but then promptly withdrew from the debate. Consumer demand promptly withdrew from the debate. Consumer demand for TTO-containing products fell, and Cropwatch has for TTO-containing products fell, and Cropwatch has evidence from one German tea tree oil toothpaste evidence from one German tea tree oil toothpaste manufacturer, whose annual usage went down from 4 manufacturer, whose annual usage went down from 4 tons/annum pre-2003, to 500Kg/annum presently.tons/annum pre-2003, to 500Kg/annum presently.

Tea Tree Oil – The Real StoryTea Tree Oil – The Real StoryCropwatch spent 18 months investigating where the Cropwatch spent 18 months investigating where the pressure for any need to establish an SCCP Opinion on pressure for any need to establish an SCCP Opinion on TTO originated. We conclude there is little evidence of TTO originated. We conclude there is little evidence of transparency over lobbying within Brussels, as has been transparency over lobbying within Brussels, as has been previously identified by the previously identified by the Corporate Europe Corporate Europe ObservatoryObservatory (Wesselius 2005). (Wesselius 2005). 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 run at of small bottles of TTO by major distributors run at

> 0.0015% (Cropwatch, unpublished data).> 0.0015% (Cropwatch, unpublished data).Cropwatch has been running a website questionnaire for Cropwatch has been running a website questionnaire for aromatherapists on TTO for several years. This is aromatherapists on TTO for several years. This is expected to report in summer 2009, and show no expected to report in summer 2009, and show no significant problems associated with TTO use in significant problems associated with TTO use in aromatherapy. aromatherapy. We conclude the regulatory action sequence against We conclude the regulatory action sequence against TTO to be misguided, unfair, to have arisen purely TTO to be misguided, unfair, to have arisen purely because of industrial lobbying, and does not serve the because of industrial lobbying, and does not serve the public interest. public interest.

Safrole: a Weak Hepatocarcinogen ?Safrole: a Weak Hepatocarcinogen ?Public resistance to over-precautious safety Public resistance to over-precautious safety legislation gets little media attention. Use of legislation gets little media attention. Use of sassafras in sassafras tea, root beer, filsassafras in sassafras tea, root beer, filèè powder powder etc. was banned in 1976 by the FDA in the US, etc. was banned in 1976 by the FDA in the US, as the main constituent, safrole, is a mild rodent as the main constituent, safrole, is a mild rodent hepatocarcinogen. There is, even today, little hepatocarcinogen. There is, even today, little new evidence for its human carcinogenicity. new evidence for its human carcinogenicity. Many sassafras tea drinkers & root beer makers Many sassafras tea drinkers & root beer makers in Eastern US regard the right to use sassafras in Eastern US regard the right to use sassafras flavouring ingredients as part of their cultural flavouring ingredients as part of their cultural inheritance. They regard the 1976 FDA ban as inheritance. They regard the 1976 FDA ban as purely purely politicalpolitical, since safrole is a precursor for , since safrole is a precursor for illicit drug manufacturing (Ecstasy etc). illicit drug manufacturing (Ecstasy etc). Safrole as an added ingredient is banned IFRA; Safrole as an added ingredient is banned IFRA; the limit for safrole from safrole-containing the limit for safrole from safrole-containing essential oils in fragranced products is 0.01%. essential oils in fragranced products is 0.01%.

Some very inconvenient classifications.Some very inconvenient classifications.SafroleSafrole: carcinogen cat. 3 mutagen cat. 2 (EFFA 2008). : carcinogen cat. 3 mutagen cat. 2 (EFFA 2008). Occurs in sassafras, nutmeg, mace, star anise & 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). LilialLilial (BMHCA): (BMHCA): Reproductive toxin cat 3. REXPAN: Reproductive toxin cat 3. REXPAN: OK to use it up to conc. limits in IFRA Standard.OK to use it up to conc. limits in IFRA Standard.EthanolEthanol:: CMR cat 1. Cosmetic manufacturers currently CMR cat 1. Cosmetic manufacturers currently withdrawing ethanol from mouthwash formulations. withdrawing ethanol from mouthwash formulations. Indispensable ingredient to cosmetics trade. Indispensable ingredient to cosmetics trade.

IFRA vs. IFRA vs. EUEU Restrictions for Methyl EugenolRestrictions for Methyl Eugenol Fine fragrance:  0.02%* Fine fragrance:  0.02%* (0.01% EU)(0.01% EU)

Eau de toilette 0.008% Eau de toilette 0.008% (0.004% EU)(0.004% EU) Fragrance cream 0.004% Fragrance cream 0.004% (0.002%% EU)(0.002%% EU)

Other leave on: 0.0004% Other leave on: 0.0004% (0.002% EU for leave-ons &(0.002% EU for leave-ons & oral hygiene products)oral hygiene products) Rinse off 0.001%Rinse off 0.001% (0.001% EU) (0.001% EU) Non skin (as defined in the introduction to the IFRA Non skin (as defined in the introduction to the IFRA

Standards): 0.02%Standards): 0.02%Other non cosmetic products not covered above: 0.001% Other non cosmetic products not covered above: 0.001%

**Conc in fragrance compound.Conc in fragrance compound.

IFRA Standard also applies to household productsIFRA Standard also applies to household productsStandards are too severeStandards are too severe, based on the available , based on the available evidence, which Cropwatch has been reviewing for the evidence, which Cropwatch has been reviewing for the last 18 months. last 18 months.

Fragrance regulation – what can be Fragrance regulation – what can be done?done?

Fragrance is used in other areas than just cosmetics: Fragrance is used in other areas than just cosmetics: e.g. household products, aerosols, environmental e.g. household products, aerosols, environmental fragrancing, candles & incense, reodourants etc. fragrancing, candles & incense, reodourants etc. Cropwatch believes there would be considerable support Cropwatch believes there would be considerable support within the European Parliament for a separately within the European Parliament for a separately established established Fragrance CommissionFragrance Commission which would which would preserve the art, culture & heritage of European preserve the art, culture & heritage of European fragrance.fragrance.Cropwatch also believes that the Ombudsman would Cropwatch also believes that the Ombudsman would take up the issues of non-transparency, ‘invisible’ take up the issues of non-transparency, ‘invisible’ lobbying and social non-accountability within the EU lobbying and social non-accountability within the EU Cosmetics Division.Cosmetics Division.The fact that the SCCP has been too over-worked to The fact that the SCCP has been too over-worked to deal with major issues within a reasonable time-frame deal with major issues within a reasonable time-frame (citrus furanocoumarins; TTO), strengthens the case for (citrus furanocoumarins; TTO), strengthens the case for an independent body of experts who are experienced an independent body of experts who are experienced with (& are focussed on) aromatic materials. with (& are focussed on) aromatic materials.

CoumarinCoumarinEFSA (2004) concluded that coumarin is non-EFSA (2004) concluded that coumarin is non-genotoxic. Any human carcinogenicity issues may genotoxic. Any human carcinogenicity issues may only be relevant to very small sub-section of only be relevant to very small sub-section of human population (Lake 1999).human population (Lake 1999).Federal Institute for Risk Assessment (BfR) had to Federal Institute for Risk Assessment (BfR) had to be publicly corrected in 2007 on alleged risks with be publicly corrected in 2007 on alleged risks with coumarin toxicity from cosmetics. The BfR had coumarin toxicity from cosmetics. The BfR had wrongly maintained that the TDI (0.1mg/d) for wrongly maintained that the TDI (0.1mg/d) for coumarin could be exceeded by application of coumarin could be exceeded by application of cosmetics. Commentators are on record as saying cosmetics. Commentators are on record as saying that Prof. Hensel has, additionally, not understood that Prof. Hensel has, additionally, not understood species differences relevant to coumarin species differences relevant to coumarin metabolism.metabolism.Full details can be found in ‘Coumarin: the Real Full details can be found in ‘Coumarin: the Real Story’ (updated Jan 2009) at Story’ (updated Jan 2009) at www.cropwatch.orgwww.cropwatch.org..

Coumarin – not a sensitiser!Coumarin – not a sensitiser!Coumarin is regulated by Coumarin is regulated by EU Directive 2003/15/EC EU Directive 2003/15/EC such such that coumarin requires labelling as a sensitiser if present that coumarin requires labelling as a sensitiser if present at concentrations of >10ppm in fragranced leave- on at concentrations of >10ppm in fragranced leave- on products, or >100 ppm in fragranced products washed off products, or >100 ppm in fragranced products washed off the skin. the skin. SCCP Opinion /0935/05 on 99.9% pure coumarin, shows SCCP Opinion /0935/05 on 99.9% pure coumarin, shows the expert committee had misunderstood the data, the expert committee had misunderstood the data, incorrectly concluding that pure coumarin is a incorrectly concluding that pure coumarin is a sensitiser sensitiser - Schnuch - Schnuch et alet al (2004), Floc’h (2004), Floc’h et alet al (2002), Vocanson (2002), Vocanson et alet al (2006 & 2007) and many others have opposing views. (2006 & 2007) and many others have opposing views. Cropwatch’s submission to DG-Ent. on coumarin was Cropwatch’s submission to DG-Ent. on coumarin was never acknowledged. never acknowledged. Minor Minor impuritiesimpurities in in somesome commercial grades of commercial grades of syntheticsynthetic coumarin used for allergy testing (dihydrocoumarin; 6-coumarin used for allergy testing (dihydrocoumarin; 6-chlorocoumarin etc.) chlorocoumarin etc.) maymay be sensitising. be sensitising. However only 1 well-documented clinically relevant case However only 1 well-documented clinically relevant case of allergy to coumarin has ever been reported (Mutterer of allergy to coumarin has ever been reported (Mutterer et et alal. 1999).. 1999).

The Oakmoss/Treemoss DebacleThe Oakmoss/Treemoss DebacleOakmoss – foundation of Coty’s Oakmoss – foundation of Coty’s ChypreChypre, Guerlain’s , Guerlain’s MitsoukoMitsouko, Dior’s , Dior’s Miss DiorMiss Dior. F. Fragrant lichen extracts are ragrant lichen extracts are the cornerstones of both the chypre & fougère accords, the cornerstones of both the chypre & fougère accords, and are immensely important to the perfumery art.and are immensely important to the perfumery art.SCCP Opinion 1131/07 limits the potent sensitisers SCCP Opinion 1131/07 limits the potent sensitisers atranol & chloroatranol to 2ppm in oakmoss, treemoss (& atranol & chloroatranol to 2ppm in oakmoss, treemoss (& cedarmoss) products. But tcedarmoss) products. But the conclusions reached in he conclusions reached in Opinion 1131/07 appear to be unsafe from a failure to Opinion 1131/07 appear to be unsafe from a failure to consider all the available evidence. Cropwatch was consider all the available evidence. Cropwatch was easily able to find this evidence via a literature search easily able to find this evidence via a literature search (see the corresponding bibliography in (see the corresponding bibliography in Cropwatch FilesCropwatch Files). ). There is a question of partiality to be answered by There is a question of partiality to be answered by individual SCCP members who were also paid individual SCCP members who were also paid researchers (according to documents seen by researchers (according to documents seen by Cropwatch). These members did not exclude themselves Cropwatch). These members did not exclude themselves from the Opinion, & are thus unethically operating as from the Opinion, & are thus unethically operating as witness, judge & jury in this matter. witness, judge & jury in this matter.

Peru BalsamPeru BalsamThe bThe bêête noir of allergenic aroma ingredients for many te noir of allergenic aroma ingredients for many dermatologists, it has medically important role in difficult- dermatologists, it has medically important role in difficult- to-heal wounds. Several perfumery companies removed to-heal wounds. Several perfumery companies removed Peru Balsam qualities from their inventories following Peru Balsam qualities from their inventories following confusion on their safety status, due to errors in 2006 confusion on their safety status, due to errors in 2006 made by EU regulatory staff. This, together with effects made by EU regulatory staff. This, together with effects of previous 1982 IFRA Standards, has reduced the use of previous 1982 IFRA Standards, has reduced the use of Peru Balsam qualities in fragrances. Curiously, as the of Peru Balsam qualities in fragrances. Curiously, as the production volume has decreased some 50% at source, production volume has decreased some 50% at source, positive patch-test frequency reactions to Peru Balsam positive patch-test frequency reactions to Peru Balsam have mysteriously increased. have mysteriously increased. Now help is needed to save the declining forest in El Now help is needed to save the declining forest in El Salvador, the balsam producing industry itself and the Salvador, the balsam producing industry itself and the communities dependent on it. The EU’s attitude is that communities dependent on it. The EU’s attitude is that the socio-economic consequences of their legislation is the socio-economic consequences of their legislation is ‘not within their remit’.‘not within their remit’.

Peru Balsam – the Real Story.Peru Balsam – the Real Story.Much/most of the Peru Balsam oil on the Much/most of the Peru Balsam oil on the commercial market is adulterated. commercial market is adulterated. Dermatologists do not use a standardised, Dermatologists do not use a standardised, authenticity-tested product.authenticity-tested product.RIFM have previously failed to identify the major RIFM have previously failed to identify the major allergens in Peru Balsam/Peru Balsam oil (such allergens in Peru Balsam/Peru Balsam oil (such as the relatively unstable coniferyl benzoate 1-as the relatively unstable coniferyl benzoate 1-9%, benzyl isoferulate to 0.4% etc.).9%, benzyl isoferulate to 0.4% etc.).Cropwatch has been working with Peru Balsam Cropwatch has been working with Peru Balsam manufacturers to try to reduce the occurrence of manufacturers to try to reduce the occurrence of the major allergens in Peru Balsam qualities the major allergens in Peru Balsam qualities without affecting their odour profile. without affecting their odour profile. Funding for this type of work is problematic. Funding for this type of work is problematic.

‘‘Allergenic’ Cosmetic IngredientsAllergenic’ Cosmetic IngredientsSCCNFP in Opinion SCCNFP in Opinion SCCNFP/0017/98 & 0329/00 identified 0329/00 identified a number of fragrance chemicals (16 of which occur in natural a number of fragrance chemicals (16 of which occur in natural products) having a labelling obligation for allergens where products) having a labelling obligation for allergens where conc. in the final product is <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 Council Directive 2003/15/EC. The basis for the inclusion of these chemicals as allergens has never been the inclusion of these chemicals as allergens has never been explained by the SCCP (Storrs 2007). The chairman of the explained by the SCCP (Storrs 2007). The chairman of the SCCP (Ian White) has co-authored a number of research SCCP (Ian White) has co-authored a number of research papers on alleged allergens, & papers on alleged allergens, & cannot be said to be a cannot be said to be a disinterested partydisinterested party..Independent papers/peer-reviews (e.g. Schnuch, Floc’h, Independent papers/peer-reviews (e.g. Schnuch, Floc’h, Vocanson, several by Hostynek & Maibach) have indicated Vocanson, several by Hostynek & Maibach) have indicated that there is no robust clinical or experimental evidence to that there is no robust clinical or experimental evidence to support many of these 26 ingredients as allergens. There support many of these 26 ingredients as allergens. There seems to be no mechanism to independently review the seems to be no mechanism to independently review the SCCP’s Opinion, or undo Directive 2003/15/EC, although SCCP’s Opinion, or undo Directive 2003/15/EC, although Schnuch (2008) asked the EU to rethink their policy.Schnuch (2008) asked the EU to rethink their policy. Hostynek & Maibach’s (2008) detailed article Hostynek & Maibach’s (2008) detailed article on “Allergic on “Allergic Contact Dermatitis to Linalool: Allergen Status Disqualified” Contact Dermatitis to Linalool: Allergen Status Disqualified” appears in a third consecutive journal/trade magazine.appears in a third consecutive journal/trade magazine.

Alleged allergens: a newAlleged allergens: a new developmentdevelopmentA 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 has been made by the EU Commission of has been made by the EU Commission of the SCCP, passed off as a spin-off from the public the SCCP, passed off as a spin-off from the public consultation (Nov 2006) on the Commission proposal of consultation (Nov 2006) on the Commission proposal of regulation of some fragrance substances.regulation of some fragrance substances."Scientific information of general and specific nature has "Scientific information of general and specific nature has been submitted to DG-ENTR. in order to ask the SCCP been submitted to DG-ENTR. in order to ask the SCCP for a revision of the 26 fragrances with respect to further for a revision of the 26 fragrances with respect to further restrictions 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” [- maybe, but any common sense wasn’t evident either!].

Alleged allergens: a newAlleged allergens: a new development IIdevelopment IISome squabbling over the substances to be Some squabbling over the substances to be considered as alleged allergens has ensued at considered as alleged allergens has ensued at the time of writing (March 2009). the time of writing (March 2009).

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

Sounds like a good idea – what Sounds like a good idea – what happened?happened?

Quote from Ian White (1998) “Fragrances – Future Quote from Ian White (1998) “Fragrances – Future Aspects” in Aspects” in Fragrances, Beneficial and Adverse of Fragrances, Beneficial and Adverse of EffectsEffects” ed. P.J. Frosch, J.D. Johansen & I.R. White, ” ed. P.J. Frosch, J.D. Johansen & I.R. White, publ. Springer 1998: publ. Springer 1998:

“ “A think tank has been set up consisting of a balanced A think tank has been set up consisting of a balanced representation of dermatologists, fragrance compound representation of dermatologists, fragrance compound manufacturers manufacturers and usersand users to address aspects of the to address aspects of the problems and needs.”problems and needs.”

[ The above quote describes a situation which seems to [ The above quote describes a situation which seems to have little resemblance to the SCCP, of which Dr. White have little resemblance to the SCCP, of which Dr. White is chairman or any other committee Cropwatch is aware is chairman or any other committee Cropwatch is aware of. Note absence of ‘of. Note absence of ‘independent independent scientists with requisite scientists with requisite cross-disciplinary skillscross-disciplinary skills’ on the 1998 wish-list]. ’ on the 1998 wish-list].

The suppression of scientific dissentThe suppression of scientific dissent““For any group that is able to acquire a For any group that is able to acquire a disproportionate share of society’s wealth, disproportionate share of society’s wealth, power, or status, it is advantageous for this power, or status, it is advantageous for this inequality to be seen as legitimate. One of the inequality to be seen as legitimate. One of the key bases or supports for legitimacy in key bases or supports for legitimacy in contemporary societies is scientific and contemporary societies is scientific and technological expertise.” technological expertise.”

“ …“ …wherever legitimacy supported by technical wherever legitimacy supported by technical expertise is important …. expertise is important …. there is a reasonable there is a reasonable chance that some cases may be found of the chance that some cases may be found of the exercise of power to suppress dissent from exercise of power to suppress dissent from dominant views.”dominant views.”

- Brian Martin (1999).- Brian Martin (1999).

AcronymsAcronymsBfR – Federal Institute for Risk AssessmentBfR – Federal Institute for Risk AssessmentBPD - Biocidal Products DirectiveBPD - Biocidal Products DirectiveCoP - Code of PracticeCoP - Code of PracticeDPD - Dangerous Products DirectiveDPD - Dangerous Products DirectiveECHA - European Chemicals AgencyECHA - European Chemicals AgencyEFFA - European Flavour & Fragrance AssociationEFFA - European Flavour & Fragrance AssociationEFSA – European Food Safety AuthorityEFSA – European Food Safety AuthorityEPA - Environmental Protection AuthorityEPA - Environmental Protection AuthorityFC – Furanocoumarin syn. FurocoumarinFC – Furanocoumarin syn. FurocoumarinGMO - Genetically Modified OrganismsGMO - Genetically Modified OrganismsH & S - Health & SafetyH & S - Health & SafetyIFRA - International Fragrance Association IFRA - International Fragrance Association ISO - International Standards Association ISO - International Standards Association MCPD - 3-monochloropropane-1,2-diolMCPD - 3-monochloropropane-1,2-diolPCB - Polychlorinated Biphenyls PCB - Polychlorinated Biphenyls QRA - Quantitative Risk AssessmentQRA - Quantitative Risk AssessmentREACH - Registration, Evaluation, Authorisation and Restriction of ChemicalsREACH - Registration, Evaluation, Authorisation and Restriction of ChemicalsRIFM - Research Institute for Fragrance MaterialsRIFM - Research Institute for Fragrance MaterialsSCCNFP - SCCNFP - Scientific Committee on Cosmetic Products and Non-Food Products. Now Scientific Committee on Cosmetic Products and Non-Food Products. Now SCCP (q.v.)SCCP (q.v.)SCCP Scientific Committee on Consumer ProductsSCCP Scientific Committee on Consumer ProductsSCF – Scientific Committee on FoodSCF – Scientific Committee on FoodSME - Small & Medium EnterprisesSME - Small & Medium EnterprisesTDI – Tolerable Daily IntakeTDI – Tolerable Daily IntakeTTO - Tea Tree OilTTO - Tea Tree Oil

References IReferences I

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

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

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

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

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