the aromaconnection blog

Powerpoint Text: Is excessive regulation destroying the perfumery art?

Presentation linked from previous post converted to a blog post by Rob.

by Tony Burfield Cropwatch  www.cropwatch.org

Safety Issues in the Aroma Business.

• Fragrance customers usually insist on adherence to all existing H&S guidelines (both official & voluntary) because of the prevailing fear-culture, and possible media exposure regarding potential adverse effects to end-users from single ‘hazardous’ fragrance ingredients.
• EU Regulators have no capability of gauging the socio-economic effects of their policies. Banning or restricting natural aromatic materials often has severe economic consequences for natural aromatic producers and dependent communities in developing countries. Disastrous EU legislation is (sometimes) followed by an impact assessment and (then possibly) corrective action – but by then its often too late to save any affected SME’s (e.g. the effect of the BPD on Europe’s natural biocidal product manufacturers).
• Knowledgeable whistle-blowers revealing questionable trade practices are shunned by the trade (for example, as detailed in the letters of the late Stephan Arctander).
• So many SME’s (candle-makers / soap-makers/ incense traders / pot pourri makers / hand-made cosmetics makers / general cleaning product makers / natural perfumers / aromatherapists etc.) cannot afford IFRA / RIFM’s annual fees, & so are locked out of access to a lot of detailed safety data.
• Perfume manufacturing orgs. require the implicit adherence of their members to IFRA Standards & CoP [note: these are not legal requirements, with the exception of Eco-label fragrances]. However many traditional perfumes types, as well as natural, organic & functional perfumes are almost impossible to construct under existing IFRA regulations.
• Safety data is often generated by the major aroma corporates in an atmosphere of secrecy & may have private ownership issues attached; data can be difficult to locate, & expensive or virtually impossible for the general public to obtain. There is also a lack of transparency by regulatory professionals.

Healthy factory environments: at least, nobody ever caught a cold!

 

The ‘Zero Risk Mindset’.

• EU Regulators apply - (or appear to have been pressurised into, by ‘invisible’ lobbyists) a disproportionate & excessive degree of regulation wrt aromatic ingredients, which appears to be an attempt to construct a clean, risk-free and largely synthetic-based world of their own. That is not the world that most of us wish to inhabit, and Cropwatch believes that many will ignore any restrictions which deny us the use of those familiar natural materials which we associate with our lives, our heritage & our traditions.

“..a society that does not try to shape its future ends up being dictated to by its own anxieties.” - Hunt (2004)

So How Dangerous is it to go Outside…?

• The green leaves of trees & plants continuously emit a- & b-pinenes, limonene etc. Shenck (1979) estimated that 438 million tons of monoterpenes* evaporate into the air continually from biological materials [*natural monoterpenes that are designated ‘dangerous for the environment’]. It has been calculated that one European forest puts more chemicals into the environment that the whole EU chemical industry.
• Emitted leaf volatiles also react with ozone to form irritating / sensitising terpene epoxides. Some US fragranced home-care products containing limonene are labelled (paraphrasing): do not use if smog outside !
• Tree leaf volatiles also react with nitrogen oxides from combustion engine emissions causing chemical smogs. Academics at Lancaster University (2002) recommended that UK councils modify the planting of certain VOC emitting trees (maple trees: good; oaks & poplars: bad!) (not, you will notice, take any steps to stop cars emitting nitrogen oxides).

Nature: Presents More Hazards than Using Fragranced Products?

• Inhalation of fern spores poses a cancer risk to countryside visitors / dwellers, & the spores are also a risk to the safety of potable water supplies (Calif. Prop 65).
• Unregulated nuisance farm crops such as mustard seed-rape (flowers & roots) emit allyl isocyanate, benzyl cyanide etc. into the air & soil. Aerial dispersion causes respiratory distress / allergy to many in vicinity (see Rapeseed report: Cropwatch Files).
• This is not to mention the unregulated intake of natural carcinogens, mutagens, toxins etc. consumed in food & spices, & beverages (e.g. methyl eugenol from pesto, safrole from nutmeg, and the CMR1 substance ethanol).

 
Crop of Unregulated Allyl Isocyanate & Benzyl Cyanide Emitters (Brassica napus L. ssp. oleifera) [i.e. Rapeseed or Canola].

Forest of Unregulated a- & b-Pinene Emitters (Pinus sp.), Finland, near Local Aquifer! (can you spot the Daphnia?)

 
Unregulated Phenylacetaldehyde Emitters Lotus corniculatus L. [Birdsfoot Trefoil] growing in the Shetlands! Photo credit: T. Burfield.

 

Unregulated Wild-Flower Coumarin Source (Melilotus officinalis L.) [i.e. Yellow Meliliot from which a perfumery absolute is made].

Unregulated Plateful of Suspected Rodent Carcinogen posing as Foodstuff [A plateful of methyl eugenol containing Pesto!].

REACH.

• Industry is seen as a cash-cow by the EU H&S Commission. REACH registration costs will potentially ruin all but the largest aroma concerns, in spite of concessions for SME’s. The aroma industry magnates therefore divisively support the REACH regulations as a means of eliminating competition.
• The ECHA has created an unmonitored situation under REACH (e.g. for lead registrants & for SIEFS etc.) where bullying and mafia-like activity by large aroma industry corporates has gone unrestricted.
• REACH will severely reduce the available portfolio of fragrance ingredients – Western companies will only be able to make ‘Mickey Mouse’ perfumes.
• REACH has already driven the focus of activity of leading trans-international aroma companies out of Europe.
• Leading toxicologists are opposed to REACH (see next slide)

The Basis of REACH challenged

• The idea that the toxic effects of a chemical show a dose-dependent linear relationship ending at a threshold level is now challenged: at low levels adaptive, non-adverse or even beneficial effects occur (hormesis), and have been shown for >6,000 chemicals (Calabrese 2004).
• This raises a ‘serious misreading of the term toxic’ charge for the EPA, and for the ECHA over the REACH legislation, and suggests that the 50-100 million Euros spent on the exercise is wasted, and will not save a single life.
• The above reference to the EPA needs to be seen as what appears to be a gagging order, mentioned a document prepared by the EPA in 2004, which states that the purpose of a risk assessment is to identify risk (harm, adverse effect etc.), effects that appear to be adaptive, non-adverse or beneficial may not be mentioned. - through Calabrese (2007) ”Belle Newsletter: Introduction. “ Human & Experimental Toxicology 26, 845.

The importance of natural aromatic ingredients.

• Naturals breathe life into an otherwise simple blend of chemicals, adding depth and sophistication - whether floral absolutes, woody materials or citrus oils are employed (many of these ingredients will disappear under REACH).
• Whole fragrance styles / families would not exist without naturals – for example, Eau de Colognes, Eau Fraiches.
• Many landmark fragrances & fragrance styles owe their conception to key natural materials e.g. the chypre style of Mitsouko & Miss Dior, which were based on accords of oakmoss, patchouli oil and labdanum together with bergamot oil.
• Many essential oils lend an incomparable radiant freshness to fragrances e.g. lime, lavender & petitgrain. It is hard to imagine an impressive masculine fine fragrance which merely relies on synthetic materials for its freshness.

A Timid Industry.

• Cosmetic / biocidal / detergent & cleaning ingredient restrictions & regulation proceed with little effective trade questioning or objection in the EU, leading to questions about why industry is so timid (see Durodie 2004).
• But ‘the worm is turning’. In the US, cosmetics-based SME’s are grouping together to prevent financially discriminating legislation acting against them – for example over the crippling fees & costs involved with compliance to the FDA Globalisation Act HR-759, 2009). The Colorado Safe Personal Products Act HB-1248 which proposed zero tolerance for many ‘hazardous’ single cosmetic ingredients (& so was potentially even more extreme than existing European legislation) failed in committee (01.03.2010) due to pressure from SME’s. In S.E. Asia, producers of natural aromatic materials & cosmetics are just starting (Feb 2010) to form anti-regulation groups to protect their livelihoods.

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

• The EU Cosmetics Commissions’ CoP refuses to define ‘safety’, there is no individual ingredient risk quantification, it does not consider ingredient risk / benefit considerations (except for preservatives), it does not allow in-use considerations, & it does not allow for end-consumer adverse reaction statistics to affect safety policy - as apparently this is not ‘bona fide’ evidence (Daskaleros 2007).
• This ‘risk-only’ chemophobic scenario leads to a state of toxicological imperialism, where over-precaution & scare-mongering are de rigueur, and where pharmaceutical & chemical company lobbying disadvantages competitive natural products. Worrying situations of vested interest (e.g. in the SCC(S)(P)) remain unaddressed. Europe has become a hostile environment for perfumery; many concerns have relocated outside the EU.

A Lack of Cross-Disciplinary Expertise..

• EU Cosmetic Comm. staff admitted to Cropwatch (Brussels 2007) they were unable to find the services of a botanical expert, and the SCCP had no literature search ability until 2007 (& so previously could not properly independently review the evidence presented to them). Now a pool of 160 ’experts’ is supposedly to be made available to Brussels staff (but no word on any botanists!).
• The previous safety assessments of many / most natural fragrance ingredients by RIFM have proceeded via industrially donated materials which have not been botanically identified at source by an expert, were not batch-tracked and not proven as 100% derived from the named botanical. The lack of forensic and taxonomic application has led Cropwatch to describe a number of IFRA Standards as non-robust, where botanical identifications (as published) are either incorrect, incomplete or based on false assumptions of ingredient purity e.g. for opoponax (see Cropwatch Files - Opoponax).

..and a Lack of Ecological Awareness..

• The industrial over-exploitation of many natural aromatic species by the Cosmetics & Pharmaceutical industries remains virtually unchecked – by the time a CITES listing or an IUCN Red Listing is in place, it is often too late to save the species under threat, or the full compliment of its’ genetic diversity.
• For example while IFRA pondered a new Standard for styrax qualities, less than 15 hectares of Asian styrax trees remained unlogged in Turkey.
• Commodities from rare or threatened species include: agarwood oil, sandalwood oil East Indian, sandalwood oil East African, rosewood oil, Cedrela odorata oil, guaiacwood oil, copaiba balsam, gurjun balsam, candeia plant spp., costus qualities, Parmelia (fragrant lichen) qualities, some frankincense yielding spp. e.g. Boswellia papyrifera, chaulmoogra oil and many others (see Cropwatch data-base on Threatened Aromatic Species).

Media Bad Science on Naturals – an Example.

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

Bad Science on Naturals in Peer-Reviewed Journals – An Example.

According to Frosch, White et al. (2002):

• patchouli oil contains cinnamic aldehyde, benzaldehyde & eugenol!
• Atlas cedarwood oil contains alpha-ionone!
• sandalwood oil contains geraniol & citronellol!
• the main components of spearmint oil are limonene, 3-octanol, menthone and dihydrocarvone (but no mention of the major constituent: carvone!)

Ref: Frosch P.J., Johansen J.D., Menné T., Pirker C., Rastogi S.C., Andersen K.E., Bruze M., Goosens A., Lepitoittevin J.P. & White I.R. (2002) “Further important sensitisers in patients sensitive to fragrances II - Reactivity to essential oils.” Contact Dermatitis 47, 279-287.

Destroying the very foundations of perfumery.

• The restriction/banning of key fragrance ingredients on dubious / over-precautionary safety grounds, can easily compromise the founding elements of the traditional perfumery art. For instance, the crucially important fougère perfumery accord consists of a combination of bergamot, coumarin & oakmoss.
• Bergamot oil usage is under threat from potential EU legislation because of its allegedly photo-toxic furocoumarin (FC) content (see flawed SCCP Opinion 0942/05, then compare with the Cropwatch FC data-base).
• Oakmoss was originally proposed to be restricted as a sensitiser under SCCP/1131/07, limiting the potent sensitisers atranol & chloroatranol to 2ppm in product. Cropwatch (2009) described this Opinion as unsafe from a failure to consider all the published evidence (which it has subsequently made publicly available). EU policy on oakmoss / treemoss has since been modified.

Public Objections to ‘Safe’ Reformulations of Classic Perfumes.

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

Natural Ingredient Usage Declines.

• The usage of naturals has declined in perfumery from downward pressure on ingredient costs (synthetics are comparatively cheaper), erratic supply (climatic & geophysical events; political events; demand pressures) & from stability & compositional issues.
• Under existing EU H&S policy, natural complex substances are treated as a collection of individual composite chemicals. The vast majority of essential oils, absolutes & resinoids contain several of the 26 named allergens, which have to be labelled under EU Directive 2003/15/EC (now under review). The desire by cosmetic manufacturers to avoid excessive product labelling has previously lead to some decline in the overall usage of essential oils.
• Under CHIP / EU DPD & DSD (now under the CLP 1272/2008/EC), R50/53 environmental labelling (dead fish / dead tree symbols) and R65 labelling have had a serious impact on usage of citrus oils & their terpenes. Citrus oils have been traditionally employed in many types of perfumes for household & air care products due to their diffusion, lift & fresh character, but perfumers now find it difficult to use them for the reasons above. Ditto for pine needle oils.
• Cinnamon leaf & clove oils were used in pot pourris & candles, but R43 issues with cinnamic aldehyde & eugenol contents etc. mean that their use is restricted.
• Minor oils that IFRA has banned / restricted on predictive toxicological grounds, but has no funds to practically investigate – melissa, santolina, boldo etc. NB Cropwatch recently published the Robertet toxicological evidence on melissa oil showing the original IFRA ban was unjustified
• Natural products needing expert botanical identification & chemical analysis for QRA studies, are/were not supported (read: can’t afford to support) by IFRA– opoponax, styrax..

The ‘Weak Animal Carcinogens’ Issue.

• The EU classification of methyl eugenol as a suspected rodent carcinogen & mutagen, and safrole as a hepatocarcinogen, together with corresponding IFRA restrictions, has led to a great reduction in the use of those natural materials which contain them, such as the methyl eugenol-containing spice oils: clove bud, pimento leaf & pimento berry. The use of rose oil has been similarly affected - it is now virtually impossible to create a 100% natural rose fragrance which complies to IFRA guidelines, formulated with >1% rose oil. Use of cinnamon leaf & nutmeg oils too, has also been curtailed by the safrole classification, as has the use of basil & tarragon oils containing estragole (weak carcinogen, weak mutagen).
• Such limitations have had significant effects on fragrance styles entering the market place: traditional aromatic masculine fougères and rich spicy notes are very difficult to achieve at so-called ‘safe’ levels.

Some Inconvenient Classifications.

• Safrole: carcinogen cat. 3 mutagen cat. 2 (EFFA CoP 2009). Occurs in sassafras, nutmeg, mace, star anise & cinnamon leaf oils.
• Methyl chavicol: Possible weak genotoxic hepatocarcinogen (SCF 2001). Occurs in star anise, exotic basil, fennel, tarragon oils.
• Methyl eugenol: Possible carcinogen (US). Calif. Prop. 65 carcinogen. Occurs in rose, basil, bay WI, cananga, citronella Sri Lanka, pimento, lovage & betel oils etc. Human exposure levels normally several magnitudes below bioassay levels for rats, mice; relevance of rodent data questioned (Robison & Barr 2006).
• Ethanol: CMR cat 1. Cosmetic manufacturers are currently withdrawing ethanol from mouthwash formulations. Indispensable ingredient to cosmetics trade.

Legislation-Compliant Ingredients?

• Cropwatch has a large A-Z data-base of articles on the various furocoumarin (FC) contents of natural products following FC phototoxicity issues (under SCCP/0942/05 etc.). Companies like Treatt, Capua etc. now market a range of FC-free citrus oils, but small traditional producers of citrus oils are potentially disadvantaged without huge technology investments. And for what reason? The safety case for reducing FC’ s to the minute levels the EU proposed in cosmetic products is not robust, and other commonly used cosmetic ingredients also show photo-toxic effects.
• To date, safrole-free nutmeg qualities, methyl eugenol-free rose oil, IFRA compliant oakmoss qualities, furanocoumarin-free bergamot oil etc. etc. have all proven to be more-easy-to-adulterate, pale olfactory shadows of traditionally produced natural products. This reduction in ingredient quality compromises the art of the possible in perfumery practice.

‘Allergic’ Fragrance Ingredients.

• SCCNFP in Opinion SCCNFP/0017/98 & 0329/00 identified a number of fragrance chemicals (16 of which occur in natural products) associated with a labelling obligation for allergens where conc. in the final product is <0.01% in products rinsed off the skin products or <0.001% in leave-on products. This was incorporated into Council Directive 2003/15/EC. The basis for the inclusion of these chemicals as allergens has never been explained by the SCCP (Storrs 2007). The chairman of the SCCP (Ian White) has co-authored a number of research papers on alleged allergens, & cannot be said to be a disinterested party.
• Independent papers / peer-reviews (e.g. those by Schnuch, Flocfh, Vocanson, several by Hostynek & Maibach) have indicated that there is no robust clinical or experimental evidence to support many of these 26 ingredients as allergens. Schnuch (2008) asked the EU to rethink their policy.
• Hostynek & Maibachfs (2008) detailed article on gAllergic Contact Dermatitis to Linalool: Allergen Status Disqualifiedh has appeared in a third consecutive journal/trade magazine.
• A request for an updated scientific opinion on the labelling of 26 fragrance substances which were introduced into Annex III of the Cosmetics Directive by 2003/15/EC was made by the EU Commission of the SCCP, politically passed off as ‘a spin-off from the public consultation (Nov 2006) on the Commission proposal of regulation of some fragrance substances’.
• "Scientific information of general and specific nature has been submitted to DG-ENTR. in order to ask the SCCP for a revision of the 26 fragrances with respect to further restrictions and possible even delisting.”
• “At that time there were not sufficient scientific data to allow for determination of dose response relationships and/or thresholds for these allergens”.

- Cropwatch comments: if this is manifestly correct, why did they go ahead with the legislation?

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

The Tea Tree Oil (TTO) Debacle

• TTO is in a Catch-22 situation. It is universally acknowledged by microbiologists as a useful biocide except by the EU Biocides Commission. Therefore, apparently, TTO in EU cosmetic products ‘does not have a cosmetic purpose’ (SCCP/1155/08).
• Also according to SCCP/1155/08, diluted TTO might be unstable in cosmetic formulations, skin & eye irritation not assessed by adequate methods. The SCCP identified data-gaps relating to subchronic toxicity, percutaneous absorption, genotoxicity / carcinogenicity & reproductive toxicity.
• The ATTIA (& RIRDC) made the big mistake of submitting a safety dossier to the SCCP on these shortcomings, at a cost of £200,000 Australian, thus creating a precedent for the whole essential oils industry. The SCCP took nearly 2 years to evaluate their data, and still were not satisfied.
• Adverse end-user reactions from sales of tens of millions of small bottles of TTO by major distributors runs at < 0.0015% (Cropwatch, unpublished data).

Vanillin

• Under IFRA’s 44th Amendment, vanillin was at first restricted on alleged QRA sensitisation grounds, but this restriction is currently suspended (this dithering costing industry hundreds of thousands of Euros in reformulation, ingredient stock adjustment, costs of buying in substitution stock and re-labelling). Current vanillin consumption is about 6,000t/y.
• Vanillin has been the foundation of the oriental fragrance family formed from accords of vanillin, balsams, spices, patchouli, woods, salicylates and citrus oils. Jicky, created in 1889 by Guerlain was the first major oriental fragrance founded on this accord.
• In the early to mid 1990s a major vanillic trend was founded on an overdose of vanillin and vanilla. Beginning with Vanilla Fields (Coty 1993), a host of sweet vanillic floral and vanillic floriental fragrances were launched e.g. Tocade (Rochas 1994), Loulou Blue (Cacherel 1995), Le Male (J. P. Gautier 1995), Allure (Chanel 1996), Ghost (2000). This trend of the 1990s has lead to a general sweetening of fragrance styles, (and consequently a generally higher use of vanillin), which is apparent today in the myriad of oriental masculine styles (e.g. 212 Sexy for Men 2006) and fruity floral feminine types and fruity florientals (e.g. Delicious Night DKNY 2007).
• Evidence for the alleged very weak sensitising activity of vanillin (according to IFRA) rests on 3 pieces of evidence, 2 of which are hardly new but are unavailable to the general public:

Basketter D.A., Wright Z.M., Warbrick E.V., Dearman R.J., Kimber I., Ryan C.A., Gerberick, G.F., White I.R. (2001). “Human potency predictions for aldehydes using the local lymph node assay.” Contact Dermatitis, 45, 89-94.

RIFM (Research Institute for Fragrance Materials, Inc.), 1970. Maximization study with vanillin. RIFM report number 1760, October 7. (RIFM, Woodcliff Lake, NJ, USA).

RIFM (Research Institute for Fragrance Materials, Inc.), 2009. Human repeated insult patch test. DRAFT REPORT. (RIFM, Woodcliff Lake, NJ, USA).

• Opposing evidence to the sensitising potential of vanillin was listed in Cropwatch Newsletter 15 – for example >99% vanillin ex lignin has been found non-sensitising. But it is likely that this major fragrance ingredient will yet suffer severe usage restrictions on dubious QRA testing grounds.

Coumarin

• Coumarin is regulated by EU Directive 2003/15/EC such that coumarin requires labelling as a sensitiser if present at concentrations of >10ppm in fragranced leave- on products, or >100 ppm in fragranced products washed off the skin.
• SCCP Opinion /0935/05 on 99.9% pure coumarin, shows the expert committee had misunderstood the data, incorrectly concluding that pure coumarin is a sensitiser - Schnuch (2004), Floc’h et al (2002), Vocanson et al (2006 & 2007) and many others have opposing views. Cropwatch’s submission to DG-Ent. on coumarin was never acknowledged.
• Minor impurities in some commercial grades of synthetic coumarin used for allergy testing (dihydrocoumarin; 6-chlorocoumarin etc.) may however be sensitising.

Only 1 well-documented clinically relevant case of allergy to coumarin has ever been reported (Mutterer et al. 1999). Low numbers of clinically relevant cases exist for many other alleged allergens listed under EU Directive 2003/15/EC. The legislation clearly lacks proportionality.

• EFSA (2004) concluded that coumarin is non-genotoxic. Any human carcinogenicity issues may only be relevant to very small sub-section of human population (Lake 1999).
• Federal Institute for Risk Assessment (BfR) had to be publicly corrected in 2007 on alleged risks with coumarin toxicity from cosmetics. The BfR had wrongly maintained that the TDI (0.1mg/d) for coumarin could be exceeded by the normal application of cosmetics. Commentators are on record as saying that Prof. Hensel has, additionally, not understood species differences relevant to coumarin metabolism.

Other Fragrance Ingredients with Questionable Restrictions.

• Benzaldehyde (used for almond & cherry notes); tagetes oils & absolutes; oakmoss & treemoss qualities; FC-containing citrus oils; opoponax & styrax qualities; jasmine absolute; santolina, boldo & melissa oils; oils of the Pinaceae.
• All of these and many others have been discussed by Cropwatch (see website), and many are the subject on on-going investigations to reverse the hasty & over-precautionary limitations imposed.

References.

• Calabrese E.J. (2004) “Hormesis – basic, generalisable, central to toxicology and a method to improve the risk assessment process” J Occup Enviro Health 10(4), 466-7.
• Calabrese E.J. (2007) ”Belle Newsletter: Introduction. “ Human & Experimental Toxicology 26, 845.
• Daskaleros T. (2007) remarks made during Cropwatch meeting with EU Cosmetics Commissioners & DG-Ent staff 2007 Brussels, July 2007.
• Durodie B. (2004) “The timid corporation – why business is terrified of taking risk.” Risk Analysis 24(1), 2004.
• EFSA (2004)
• Floc’h F. (2002) “Coumarin in plants and fruits: implications in perfumery.” Perf. & Flav. 27 (Mar/Apr 2002), 32-36.
• Frosch P.J., Johansen J.D., Menné T., Pirker C., Rastogi S.C., Andersen K.E., Bruze M., Goosens A., Lepitoittevin J.P. & White I.R. (2002) “Further important sensitisers in patients sensitive to fragrances II - Reactivity to essential oils.” Contact Dermatitis 47, 279-287.
• Henley D.V., Lipson N., Korach K.S., Bloch C.A. (2007) “Prepubertal gynecomastia linked to lavender and tea tree oils.” New England Journal of Medicine 356 (5), 479–485.
• Hostynek J. & Maibach H. (2008) “Allergic contact dermatitis to linalool” Perfumer & Flavourist 33, 52-56.
• Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that anisyl alcohol causes allergic dermatitis?" Exog. Dermatol. 2, 230-33.
• Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that amylcinnamic aldehyde causes allergic dermatitis?" Exog. Dermatol. 3, 35-46.
• Hostynek J.J. & Maibach H.I. (2003) "Is there evidence that linalool causes allergic dermatitis?" Exog. Dermatol. 2, 223-229.
• Hostynek J.J., Maibach H.I. (2004) “Is there evidence that geraniol causes allergic contact dermatitis?” Exog. Dermatol. 3(6), 318-331.
• Hostynek J.J., Maibach H.I. (2004) “Sensitisaton potential of citronellol” Exog Dermatol 3(6), 307-312.
• Hostynek J.J., Maibach H.I. (2004) “Is there evidence that alpha-methyl-ionone causes allergic contact dermatitis?” Exog. Dermatol. 3(3), 121-143.
• Hostynek J.J., Maibach H.I. (2006) “Is there evidence that alpha-methyl-ionone causes allergic contact dermatitis?” Cutaneous & Ocular Toxicol. 25(4), 259-271
• Hunt B. (2004) The Timid Corporation – Why Business is Terrified of Taking Risk
• Lake B.G. (1999) “"Coumarin metabolism, toxicity & carcinogenicity: relevance for human risk assessment" Food and Chemical Toxicology 37, 423-453
• Lawrence B.M. (2007) “Estrogenic activity of lavender & tea tree oils Part II.” Perf. & Flav June 2007.
• Mutterer V., Giménez Arnau E., Lepoittevin J.P., Johansen J.D., Frosch P.J., Menné T., Andersen K.E., Bruze M., Rastogi S.C., White I.R. (1999) "Identification of coumarin as the sensitizer in a patient sensitive to her own perfume but negative to the fragrance mix." Contact Dermatitis. 40(4):196-9.
• Nielsen J.B. (2008) “What you see may not always be what you get – Bioavailability and extrapolation from in vitro tests.” Toxicology in Vitro
• Newman N. (2002) "Big Pharma, bad science." The Nation 25 July 2002.
• Robison S.H. & Barr D.B. “Use of biomonitoring data to evaluate methyl eugenol exposure.” Environ Health Perspect. 114(11), 1797-18001.
• Schnuch A. (2004) Öko-Test, No. 7 (July) 2004, 55
• Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) “Sensitization to 26 fragrances to be labelled according to current European regulation. Results of the IVDK and review of the literature.” Contact Dermatitis. 57(1),1-10.
• Shenck G.O. (1979) Perf Kosm 60, 397.
• Storrs F.J. (2007) “Allergen of the year: fragrance.” Dermatitis 18(1),3-7
• Turin L. (2007) “Due Credit” NZZ Folio 04/07.
• Vocanson M. (2006). "The skin allergenic properties of chemicals may depend on contaminants – Evidence from studies on coumarin." Int Arch Allergy Immunol 140, 231–238
• Vocanson M. et al. (2007) “Lack of evidence for allergenic properties of coumarin in a fragrance allergy mouse model.” Contact Dermatitis 57(6), 361-364.

Acronyms.

• ATTIA – Australian Tea Tree Industries Association
• BfR - Federal Institute for Risk Assessment
• BPD – Biocidal Products Directive
• DG-ENT - Directorate General (Branch of European Commission responsible for Industry)
• CoP – Code of Practice
• E.O. – Essential Oil
• ECHA - European Flavour & Fragrance Association
• EFSA - European Flavour & Fragrance Association
• FC – FuroCoumarin
• H&S – Health & Safety
• IFRA - International Fragrance Association
• QRA - Quantitative Risk Assessment
• REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals
• RIFM - Research Institute for Fragrance Materials
• RIRDC – Rural Industries Research & Development Corporation (Australian Govt).
• SCCNFP - Scientific Committee on Cosmetic Products and Non-Food Products
• SCCP - Scientific Committee on Consumer Products
• SCF – Scientific Committee on Food
• SME – Small to Medium sized Enterprise
• TDI - Tolerable Daily Intake
• TTO – Tea Tree Oil
• VOC – volatile organic carbons

Editors Note: This was converted from a Power Point document by Rob. The formatting of the references is incomplete, and I did not add links to many previous posts on this blog which deal with many of the materials discussed herein. Those may come later, as will the reference formatting.

Technorati Tags: perfumery,natural perfumery,perfume ingredient safety,perfume ingredient regulation

Is excessive regulation destroying the perfumery art?

I (Tony Burfield) gave a talk entitled “Is excessive regulation destroying the perfumery art?” at the British Society of Perfumers Safety Symposium, 11th March 2010, held at the Belfry Hotel near Cambridge, UK; a Power Point version of the talk can be downloaded at http://www.cropwatch.org/Tony Burfield's talk to BPS final.ppt ). In contrast to the other speakers, who mainly advised on how to conform to the minutiae of existing REACH requirements, the new Classification, Labeling & Packaging (CLP) of substances & mixtures regulations, and other EU measures (as well as adherence to the IFRA CoP), I attempted to outline the disproportionate nature of EU Cosmetics legislation, and its attempts to create an artificial world of synthetic based products which would be safer than nature itself. I asked why the aroma industry had been so timid in the face of the burgeoning legislation which would all but destroy it, and why it couldn't find the time to challenge much of the bad science behind some of the more over-precautionary measures.

In a previous feature "Perfumers and the 40th IFRA Amendment" (Burfield 2007) first put out on Basenotes in Feb 2007, I had noted the declining importance & influence of the Professional Perfumer, no longer the courageous and opinionated artists, and rarely seen any more as company board members. Their decline in industrial status, often to a level slightly under that of the Regulatory Affairs Assistant, is even more evident now that previously. Yet I was informed one by a well-known perfumer working for one of the major fragrance corporates, that the new generation of software-using perfumers have no problem in conforming to the avalanche of new regulations. I interpret this as referring to a younger generation who have probably never smelled a genuine ylang-ylang oil, or an unadulterated sandalwood oil East Indian (as they are invariably ‘extended’ at source), and have a sparse knowledge or experience of the massive range of exotic natural aromatic materials. I further contend that they may well spend most of their working time tinkering with formulae, working on substitutions for contra-indicated ingredients such as cyclamen aldehyde, lyral, lilial or polycyclic musks, or lately even key materials like linalol (current shortage of this important ingredient apparently due to fire in a major producing facility in China).

Where do we go from here? With the impact of REACH set to remove a huge number of ingredients (both synthetic and natural) from the perfumers palette, and with over-exploitation continuing to endanger the future availability many natural aromatic materials, it is hard to see much future for the perfumery art in Europe, unless marketeering hype can induce consumers to buy products only suitable for consumers with unsophisticated tastes & perceptions. As previously mentioned, many consumers are noticing the increasing evidence of 'chemical' notes creeping into fragrances, and some have used fairly negative odour descriptors to Cropwatch about individual perfumes (out of the multitude of today's short-lived fragrance launches) which they perceive as smelling like 'cough candy', 'fly spray' or 'drain-cleaner'. I contend that the time is right for the centre of creativity, and progress in the art-of-the possible in fragrance design to move away from the West with its over-cautious ingredient restrictions. The toxicologists, who now seem to call the shots in this profession, have helped ruin the aroma industry, yet can only point to a vanishingly small number of instances where any alleged adverse consumer effects from fragrances have manifested as clear cut clinical cases. The future of perfumery surely lies outside the West, in countries which have more proportionate and should we say, a less hysterical approach to cosmetics health & safety regulation.

Tony Burfield
for Cropwatch.

Technorati Tags: perfumery,natural perfumery,IFRA,REACH,BPS,British Society of Perfumers

Tunnel vision

by Robert Tisserand
Reprinted with permission

People should expect reasonable and sensible protection from harm by those who regulate consumer products, and vulnerable groups such as children and pregnant women may need special consideration. Therefore, cosmetics that are totally free of all carcinogens and teratogens may sound like a good idea. But is it realistic? And is more legislation needed?

One problem is in that word “totally”. If you want to avoid encountering one molecule of a toxic substance, then you need to either live in a bubble, or stop eating, drinking, and breathing. Traces of cyanide, for instance, are found in foods and beverages, both natural and manufactured. That doesn’t mean its OK to consume in quantity, but toxicity is avoided by limiting the permitted amount to a few parts per million. The same goes for heavy metals and in fact most other toxins.

Why not zero tolerance? Well, in many cases it is both unrealistic, and unnecessary. All toxic substances have NOAELs (No-Adverse-Effect-Levels) even carcinogens. NOAELs are established in animal studies, and then ratcheted down by 100 or 500 or 1,000 times. These mathematical excursions are a bit arbitrary sometimes, but if anything, they result in too much protection, not too little.

A “zero tolerance” bill is on the table in the state of Colorado, and you can find more information about it here and here. Enacting this bill would mean, for example, that any amount of acetaldehyde would not be permitted in personal care products. Your body produces acetaldehyde whenever you drink alcohol, as it’s the major metabolite of ethanol. And chronic alcoholism can lead to cancer, with acetaldehyde the main suspect. Acetaldehyde is also a trace constituent of apples, bananas, bilberries, cherries, citrus fruits, cranberries, grapes, olives, passionfruit, peaches, plums, strawberries, raspberries, carrots, celery, cucumbers, garlic, onions, peas, potatoes and tomatoes. So, goodbye fruit extracts in cosmetics.

If you see a strawberry only as something that contains acetaldehyde (tunnel vision), then suddenly, everything you thought was good for you, is now bad for you. But (problem number two), fruits and vegetables contain a plethora of antioxidants and antimutagens that more than compensate for any toxicity from the tiny traces of acetaldehyde they contain.

Also, goodbye to rose otto and rose absolute. It was nice knowing you. And so long to nutmeg oil, mace oil, myrtle oil, basil oil, holy basil oil, citronella oil, ho leaf oil (linalool ct), elemi oil, and many other less common essential oils. Not because they contain acetaldehyde, but because they contain methyleugenol (ME). ME is occasionally found in traces in rosemary oil, clove oil, hyssop oil, tea tree oil, cananga oil, mastic oil, cassia oil, cinnamon leaf oil, savory oil, black pepper oil and, again, many others. Have you eaten any fresh basil or pesto lately? Then you have been consuming ME. But, neither fresh basil nor pesto is carcinogenic, because they also contain antimutagens and anticarcinogens that counteract any toxic effect of ME. I’m not just saying this, it has been demonstrated. The same goes for holy basil oil, to take one example – not only is it non-carcinogenic, but it is actually anticarcinogenic. The high content of geraniol in rose otto is almost certainly protective because of its anticarcinogenic action.

Does this make a difference? Not if you have tunnel vision.

The Environmental Working Group (and associated Skin Deep and Campaign for Safe Cosmetics) is an increasingly vociferous pressure group, which is now flexing its political muscle. Everywhere these people look, they find dangerous toxins, and guess what – if you look for them you will find them. And, if your vision becomes so narrow that all you can see is toxins, and the poor fetuses and children that you convince yourself they must be harming, it becomes difficult to take a step back and see the big picture. The EWG do not seem to appreciate that finding a substance in human tissue does not necessarily mean that the owner of that tissue has been harmed.

Risk assessment has many facets (problem number three) but basically it is about deciding whether exposure to a substance in a particular way is or is not actually harmful, and where safety thresholds lie. Risk assessment is not about scaremongering, it’s not about getting people fired up about “chemicals”, and it should not be about pre-emptive and sweeping legislation. It should be about ensuring safety by looking at all aspects of a problem, and then making the best decision you can. I agree with many of the EWG campaigns. It’s just a shame that they have adopted the same “single-chemical” view of essential oils that has infected the EC legislation.

If you live in Colorado and you agree with my opinion, you should act. If you don’t live in Colorado stay vigilant, because there’s more of the same on the way.

Robert Tisserand is an esteemed aromatherapy educator, author, founder of the Tisserand Institute and consultant to the personal care products industry.

Colorado Safe Personal Care Products Act : Take Action Immediately

by Kayla Fioravanti
Reprinted with permission

If you live in Colorado or sell cosmetics into Colorado it is time for you to speak up.  Colorado has a proposed a bill before them during this session known as The Colorado Safe Personal Products Act.  This Act is so broad and vague that if it passes in this form the personal care shelves in stores would go bare.  You can read the entire bill here.  To follow the bill as it is updated click here and change the range to House Bills 1201-1250 and then scan down to 1248.   

As of February 3, 2010 the bill was assigned to House Judiciary Committee. There is a hearing scheduled March 1, 2010 for sponsors and those opposing the act to be heard.  The committee meets in room 0107 (in the basement of the Capitol) beginning at 1:30 pm.

You can find the phone number and email addresses of your Colorado State Representative here.  The bill is sponsored in the house by Dianne Primavera phone # 303-866-4667 click here to email, Dennis Apuan phone # 303-866-3069 click here to email, Karen Middleton phone # 303-866-3911 click here to email, Joe Miklosi Cap phone # 303-866-2910 click here to email. 

The Women's Lobby of Colorado is holding open meetings.  They support this bill and even have the Campaign for Safe Cosmetics logo on their website.  Sadly, they have fallen for the bad science that the Campaign for Safe Cosmetics is using to cause hysteria.  The voices of small businesses in the personal care industry need to be heard.  The Women's Lobby of Colorado meetings are held at Colorado Education Association on the corner of Colfax and Grant—1500 Grant St—from 12:00-1:15 pm in the Bluebell Room. You can park free in their lot if you sign in in the lobby. Lunch will be provided. Upcoming meetings will be held March 3, March 17, March 31, February 3, April 14 and April 28. 

I will go into the faults of this bill in greater depth within the next few days, but in the mean time let me point out some of the serious flaws of this bill. 

"The bill creates the "Colorado Safe Personal Care Products Act" (act), which prohibits a manufacturer from knowingly selling, offering for sale, or distributing for sale or use in Colorado on and after September 1, 2011, any personal care product that contains a chemical identified as causing cancer or reproductive toxicity."  HOUSE BILL 10-1248

Quick Response:  Will these chemicals be ones that cause cancer when topically applied at normal usage percentges or will this information come from studies in which rats were injected with 100% concentration of said ingredients?  There is a big difference between putting an diluated ingredient on the skin than injecting an ingredient into the body at full concentration. 

"THE GENERAL ASSEMBLY (23) DECLARES IT TO BE IN THE BEST INTEREST OF THE PEOPLE OF THIS STATE (24) TO TAKE STEPS TO ENSURE THAT PERSONAL CARE PRODUCTS SOLD AND (25) USED IN THIS STATE ARE SAFE AND DO NOT CONTAIN SUBSTANCES THAT (26) CAUSE CANCER OR REPRODUCTIVE TOXICITY."  HOUSE BILL 10-1248

Quick Response:  There should be acceptable limits set and not a complete ban on ingredients.  Many things in nature in high doses are known to cause cancer; for instance the sun! 

"2 (1) "AUTHORITATIVE BODY" MEANS THE FOLLOWING AGENCIES OR (3) FORMALLY ORGANIZED PROGRAMS OR GROUPS RECOGNIZED AS (4) AUTHORITATIVE FOR PURPOSES OF IDENTIFYING CHEMICALS THAT CAUSE (5) CANCER OR REPRODUCTIVE TOXICITY:

6 (a) THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, (7) OR ITS SUCCESSOR AGENCY;

(8) (b) THE UNITED STATES FOOD AND DRUG ADMINISTRATION, OR ITS (9) SUCCESSOR ENTITY;

10 (c) THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND (11) HEALTH, OR ITS SUCCESSOR ENTITY;

12 (d) THE NATIONAL TOXICOLOGY PROGRAM, OR ITS SUCCESSOR 13 PROGRAM; AND

14 (e) THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, OR (15) ITS SUCCESSOR AGENCY." HOUSE BILL 10-1248

Quick Response:  I think this portion of the bill gets to the heart of the Environmental Working Group (EWG), aka Skin Deep, aka Campaign for Safe Cosmetics entire agenda.  The EWG wants to be that "or successor agency" mentioned in in the above list, my guess is the United States Food and Drug Administration (FDA).  The Cosmetic Ingredient Review Expert Panel is not listed as a resource for information on cosmetic ingredient safety.  Having any open ended "or successor agency" declare what causes cancer and what doesn't is dangerous. 

The EPA is an interesting choice as an expert on cosmetics.  I read over there list of cancer causing chemicals and only a very small handful are used in cosmetics at all.  I will give further detail on this list and provide a link to it this week. 

"5 25-5-1204. Prohibition - sale of personal care products (6) containing unsafe chemicals. ON OR AFTER SEPTEMBER 1, 2011, A (7) MANUFACTURER SHALL NOT SELL, OFFER FOR SALE, DISTRIBUTE FOR SALE, (8) OR DISTRIBUTE FOR USE IN THIS STATE ANY PERSONAL CARE PRODUCT (9) THAT CONTAINS A CHEMICAL IDENTIFIED AS CAUSING CANCER OR (10) REPRODUCTIVE TOXICITY. (11) 25-5-1205. Enforcement by private citizens - civil penalty. (12) (1) ANY PERSON ALLEGING A VIOLATION OF SECTION 25-5-1204 MAY (13) BRING AN ACTION AGAINST THE MANUFACTURER IN A COURT OF (14) COMPETENT JURISDICTION IN THE COUNTY WHERE THE VIOLATION (15) OCCURRED. UPON FINDING A VIOLATION, IN ADDITION TO ANY OTHER (16) RELIEF AUTHORIZED BY LAW, THE COURT SHALL ORDER THE (17) MANUFACTURER TO CEASE AND DESIST CONDUCT VIOLATING SECTION (18) 25-5-1204 AND SHALL ORDER THE MANUFACTURER TO PAY THE (19) PREVAILING PARTY REASONABLE ATTORNEY FEES AND COSTS.

20 (2) A MANUFACTURER THAT VIOLATES SECTION 25-5-1204 IS (21) SUBJECT TO A CIVIL PENALTY OF UP TO FIVE THOUSAND DOLLARS PER (22) VIOLATION PER PRODUCT FOR A FIRST OFFENSE, AND UP TO TEN THOUSAND (23) DOLLARS PER VIOLATION PER PRODUCT FOR A SECOND OR SUBSEQUENT (24) OFFENSE. PENALTIES COLLECTED PURSUANT TO THIS SECTION SHALL BE (25) DEPOSITED IN THE GENERAL FUND." HOUSE BILL 10-1248

Quick Response: Translation, the State of Colorado cannot afford to enforce this insane bill so they are leaving it in the hands of citizens to sue cosmetic companies.  After California passed California Proposition 65 there was wide spread abuse.  The lawyers got rich in California and companies wasted countless man hours and dollars defending themselves from all these lawsuits. 

This bill does not address "naturally occurring" substances found in natural ingredients.  For instance, lead would be banned, but lead is in water and cosmetics contain water.  The issue is severely complicated with naturally occurring substances since there is a complete ban and not tolerable levels.

A great example of by-product of some cosmetics is formaldehyde. In 1987, the U.S. Environmental Protection Agency (EPA) classified formaldehyde as a probable human carcinogen under conditions of unusually high or prolonged exposure.  In cosmetics there is not an unusually high or prolonged exposure to formaldehyde.  tissues. Formaldehyde is water soluble and is not stored in fat so it can be metabolized very quickly with a half life in the human body of about 1.5 minutes.

For a list of formaldehyde preservatives read here.  Formaldehyde is naturally produced our bodies, the air that we breathe, and even the food we eat.  Formaldehyde is emitted as a natural by-product in the cooking of certain vegetables like, Brussels sprouts and cabbage.

How many small companies could afford to do business in Colorado if this bill passes as it is written today?  Would you risk being fined $5000 or $10,000 when citizen take up bounty hunting cosmetic products for the promised cash reward?  If you were completely innocent could you afford to defend yourself from these potential lawsuits?

Notes & News

The authors at aromaconnection have been otherwise occupied and we apologize that it’s been rather silent here of late.  We’ll be placing some major reprints of interest in the next few days.  In the meantime, here are a couple of items in the news.

According to Cosmeticsdesign.com, the EPA has issued the first of its Chemical Action Plans (CAPs) that appear to strengthen the agency’s authority regarding laws that protect Americans from exposure to harmful chemicals.  With this move, the EPA appears to have a new focus on phthalates and is, of course, challenged by the American Chemistry Council (ACC).  The complete EPA Phthalates Action Plan can be read here. In addition to being used as a chemical ingredient to soften vinyl plastics, Diethyl phthalates (DEP) are used as a dispersing agent for reed diffusers, a popular method of adding fragrance to the household environment. Most natural products companies avoid use of DEP and you will find cautions for its use from aromatherapy companies who choose to not use synthetic chemicals.   The EPA has previously established the Endocrine Disruptor Screening Program beginning in 2009, with the Notice of Tier 1 Screening of the first 67 chemicals to be evaluated (order issuance for Diethyl phthalate Jan 2010).  We will be watching the evaluations and update EPA resolutions as they come about.

Robert Tisserand has launched a new website which includes his I’m Just Saying blog which is a welcome new addition to internet discussions surrounding aromatherapy and the use of essential oils.

Cropwatch Newsletter 16: Disproportionate Reactions to Health & Safety Issues

Cropwatch Newsletter 16 has been received by email subscribers. Contents include the following:

• DEFRA vs Georgina Downs
• IFRA & Transgressors
• Robertet Reveals its Evidence on Melissa oil
• Safrole & Human Carcinogenicity?
• EU Commission’s Proposals to Limit FC’s in Cosmetic Products
• Cropwatch’s Letter Objecting to EU Proposals on FC’s Limits
• Save Our Herbs Campaign: Press Release/Website.

It’s also available online in pdf format.

Note that you can sign up on the Cropwatch website to receive their newsletters via email, usually a few days in advance of their online posting. Several of the articles in the Newsletter were previously posted on this blog, but there is a lot of additional information available in the Cropwatch Newsletters.

Technorati Tags: Cropwatch,Cropwatch Newsletter

Safrole: Human Carcinogenicity Risk Over-Stated?

Copyright © Tony Burfield September 2009.

Updated to include additional references 9/19/2009

Preamble

It almost borders on the heretical, perhaps, to suggest that the risk of human carcinogenicity from exposure to dietary safrole has been over-estimated over the years by some toxicologists, and that the existing national & international restrictions on safrole-containing ingredients & end-products can be seen as over-precautious. Weighing the evidence, a convincing case can be made that the human carcinogenic potential of safrole, if not quite negligible at low doses, is considerably less than that of ethanol (Duke 2002). As it is, the existing evidence for the carcinogenicity and genotoxicity of safrole mainly rests on a battery of experiments performed 30-40 years ago, on laboratory rodents dosed with high levels of safrole, where electrophilic metabolites generated by P450 enzymes and sulphurotransferases are identifiable as being responsible for the genotoxicity (see Cropwatch’s extensive Safrole Bibliography at http://www.cropwatch.org/Safrole Bibliography.pdf). Different expert judgments have been made about the risk to humans from alkylbenzenes such as safrole, methyleugenol & estragole, and indeed on the relative importance for human cancer of low-dose exposures to synthetic chemicals generally (Gold et al. 1992). More insight into bioactivation of these (alkylbenzene) compounds in humans has been said to be required to interpret animal data to the human situation (Jeurissen 2007).

Safrole (4-allyl-1,2-methylenedioxybenzene; CAS No. 94-59-7) is known to occurs in the following natural products:

• Chinese Angelica (Angelica sinensis L.)
• Betel oil (Piper betle L.)
• Brown & yellow camphor oil (fractions of Cinnamomum camphora L.) Yellow oil to 20%; brown oil to 80%.
• Cangerana oil (Cabralea cangerana Saldanha)
• Cinnamon leaf oil & bark oils (Cinnamomum zeylanicum Blume) both to 2%
• Kuromoji oil (Lindera spp.) to 12%
• Mace oil (Myristica fragrans Houtt.) to 2%
• Mango ginger oil (Curcuma amada Roxb.) to 9.5%
• Nutmeg oils [E.I. & W.I.], butter & oleoresins (Myristica fragrans Houtt.) E.I, to 2%; W.I. to 0.3%’
• Pepper oil, black (Piper nigrum L.)
• Piper auritum HBK oil to 90%
• Sassafras oils, bark of roots, infusions of roots (Sassafras albidum (Nutt.) Nees to 95%.
• Sassafras oil Brazilian: Ocotea pretosia (Nees) Mez, to 92%
• Star Anise oil (Illicium verum Hook f.)
• Ylang-ylang oils, absolutes (Cananga odorata (DC) Hook. f et Thoms ­subsp. genuine)

…as well as in several other Cinnamomum essential oils (C. burmanni; C. porrectum; C. rigidissum etc.). It also in occurs in witch-hazel (Hamamelis viginiana L.), hoja santa leaves (Piper auritum HBK) and in other natural herbal & spice products & preparations.

Safrole is currently classified as a carcinogen category 2 and mutagen category 3 in the IFRA-IOFI labeling manual 2009. Since out of the three alleged human carcinogens: safrole, estragole and methyl eugenol, safrole is arguably the weakest (see below), these classifications seem somewhat arbitrary.

Substance	Hazard symbol	Risk phrases	Carcinogen category	Mutagen category
Safrole	T	R45-22-68	2	3
Estragole	Xn	R22-40-43-68*	3	3
Methyl eugenol	Xn	R22-40-68*	3	3

Classification of some Carcinogens & Mutagens according to the IFRA-IOFI Labelling Manual 2009

[*Thanks to Penny Williams of Formpak Ltd. for drawing our attention to this labeling issue; further implications over R68 status for estragole & methyl eugenol affecting common essential oils such as Aniseed, Bay, Basil, Fennel and Pine Oil Yarmor, are discussed at http://www.formpak-software.com/active/2009/09/estragol-methyl-eugenol-r68/].

Previously the IARC had surmised that safrole was “Reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals” (IARC 1976); but that “No adequate human studies of the relationship between exposure to safrole and human cancer have been reported” (- IARC 1976). The weak potency of safrole as a carcinogen is illustrated by the fact that level of safrole in the diet of rats necessary to elicit liver tumors ranges from 0.5% to 5.0% (Patri et al. 2002). The TD₅₀ for safrole in rats was found to be 440mg/Kg/d (Gold et al.) compared with 51mg/Kg/d for mice. This compares with a TD₅₀ value for methyl eugenol of 20mg/Kg/d for rats and 19mg/Kg/d for mice. However the TD₅₀ for the proximate carcinogen 1’-hydroxysafrole was found to be 18mg/Kg/d for rats compared with 71 mg/Kg/d for mice.

The hazardous dose of sassafras oil for humans (which typically contains 80% safrole) has been put at 0.66 mg/Kg, based on experimental animal data, and a safety factor of x100; this is claimed to be way- exceeded by imbibing a standard portion of sassafras tea which has been estimated to give a dose of 3mg/Kg for a 60Kg man (Bisset 1994; Segelaman 1976). By comparison Levy (Levy undated) gives a figure of 20 ppm safrole content of root beer before the sassafras FDA prohibition, approximating to a 5mg dose for an 8oz serving. Safrole-free extracts of sassafras have been approved by the FDA for food flavouring use, but apart from being organoleptically inferior, it is also of note that safrole-free extracts of sassafras have produced malignant mesenchymal tumors in laboratory rats (Benedetti et al. 1977).

Safrole & sassafras oil were banned as food & flavouring additives by the FDA on 3^rd Dec 1960 (FDA Ban 21 CFR 189.180; revised April 1 2008), the ban now includes isosafrole & dihydrosafrole (the latter not being known in nature), & sassafras root bark, but in practice both sassafras oil and bark are still widely available in the US, from health food stores and internet suppliers. Safrole appears in Annex II/360 of the EU Cosmetics Directive EU 76/768, and its concentration is limited to 100ppm in finished cosmetic products (50 ppm for oral/dental use; zero for children’s toothpaste). IFRA prohibits the addition of safrole to fragrances as such, and limits the safrole content of perfumes formulated with safrole-containing essential oils (basil, nutmeg, sassafras, cinnamon leaf etc.) to 0.01% (100ppm) for both skin contact & non-skin contact fragrances. These restrictions have caused a significant problem with certain fragrance styles entering the market place – for example in the deployment of cinnamon & nutmeg ingredients in masculine fougères and spicy masculine notes.

The restriction of safrole to low levels in foodstuffs was originally considered to be a threat to the economic welfare of the nutmeg trade, and so exceptions were made (note that curiously, no such exceptions are ever made for natural ingredients in the cosmetics area, presumably because academic ‘expert’ committees in this field are unable to accurately predict the socio-economic effects of their policies). European Council’s Directive on food flavourings 88/388/EEC, amended by 91/71/EEC and implemented into UK national law in the Flavourings in Food Regulations 1992, limits safrole in foodstuffs to 1ppm, except for foodstuffs containing nutmeg (15ppm) or alcoholic drinks >25% volume alcohol (5ppm) and other alcoholic drinks (2ppm). It is of interest to note that Choong & Lin (2001) analysed 25 soft drinks, including Coca-cola and Pepsi, from supermarkets & convenience stores in Tainan and Pingtung, for safrole and isosafrole contents in 1998, finding 20 out of 25 soft drink samples contained safrole and/or cis-isosafrole and the contents of safrole were up to 3-5 times the use limit of 1μg/mL according to the food additive regulations.

Isosafrole (CAS No. 120-8-1), which occurs as (E)- & (Z)- geometric isomers, is a weak, non-genotoxic rodent hepatocarcinogen, classified as a carcinogen category 3 (IARC 1987) which has been alleged to occur in minor amounts in certain essential oils (such as Chinese angelica oil from Angelica polymorpha Max.), ylang-ylang & nutmeg oil & oleoresin, but Lawrence could not confirm its presence in nutmeg oils (Lawrence 1990), and MAFF have disputed its presence in ylang ylang & sassafras products (MAFF 1996a). However MAFF (1994) found 0.1% to 3.4% isosafrole (av. 0.3%) in 10 analysed samples of nutmeg oil and 0.1 to 2.7% (av. 0.9%) in 3 analysed nutmeg oleoresin samples (origins not disclosed). Since isosafrole usually co-occurs with safrole in certain natural products, at concentrations typically an order of magnitude lower than the safrole concentration (MAFF 1996), it was proposed by MAFF that isosafrole is an artifact formed during the processing of safrole-containing raw materials.

Safrole Metabolism

Intraperitoneal dosing of rats and guinea pigs with safrole produces the following urinary metabolites; 1,2-dihydroxyl-4-allylbenzene, 1'-hydroxysafrole, 2-methylenedioxy-4-(2,3-dihyroxypropyl)benzene, 1,2-dihydroxy-4-(2,3-dihydroxypropyl)benzene, 2-hydroxy-3-(3,4-methylenedioxyphenyl) propanoic acid, and 3,4-methylenedioxybenzoylglycine (Stillwell et al. 1974). Two pathways have been proposed whereby hepatotoxic substances are produced from safrole (Dietz & Bolton 2007). The first proceeds via the P450 catalyzed hydroxylation of safrole to 1'-hydroxysafrole, and its subsequent conjugation with sulfate to produce a reactive sulfate ester, which creates creates a highly reactive carbocation via a SN1 displacement, which alkylates DNA. The second pathway involves the formation of hydroxychavicol via the P450 catalyzed hydroxylation of the methylenedioxy ring of safrole, which is subsequently oxidized to an o-quinone, which non-enzymically isomerizes p-quinone methide. Dietz & Bolton (2007) consider that these experiments by Bolton et al. (1994), Miller et al. (1985), Boberg et al. (1983), Daimon et al. (1997-1998) & Jeng et al. (2004) and the in vitro & in vivo experiments of Luo & Guenthner (1997), Gupta et al. (1993), Randerath et al. (1993), Daimon et al. (1998) & Daimon et al. (1997) prove the genotoxic effects of safrole and justify the regulatory action of the FDA & other authorities. Cropwatch takes issue with this conclusion; the mere existence of pathways in rodents fed high levels of dietary safrole which give rise to certain hepatotoxic substances does not, of itself, prove the potential for human carcinogenicity under normal living circumstances.

Although small amounts of safrole (0.63mg/Kg) have been shown to be cleared almost completely from the body within 24 hours in man & rats (Benedetti et al. 1977), the main urinary metabolite of safrole dosed in larger amounts is 1,2-dihydroxy-4-allylbenzene in both rats & man; 1’-hydroxysafrole and 3’-hydroxyisosafrole were also detected in the urine of the rat, but not of man (Benedetti et al. 1977). Jeurissen (2007) has identified the human P450 enzymes involved in the 1’-hydroxylation of safrole, where important roles for a series of enzymes via a series of in vitro experiments were postulated. Lifestyles factors which may lead to poor or extensive metaboliser phenotypes, which either reduce or increase the relative carcinogenicity risk, were discussed.

Also compelling evidence for humans, perhaps, lies with studies made of habitual quid chewers of betel & areca nut, where a constant body-loading of safrole may give rise to tumors over an extended time period. In particular, inflorescences of betel have been shown to contain relatively high (15mg/Kg) concentrations of safrole.

Conclusion

The classification of safrole as a Category 2 human carcinogen and the association of risk phrase R22-45-68 with the material seems disproportionate to the risks involved to humans from its traditional uses in spices, flavours, fragrances etc. Regulators appear to be forced by some unseen hand to deny the use of any traditional natural ingredients which have been shown to carry some health risks to susceptible animals at high doses, in 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 materials which we associate with our lives, our heritage & our traditions.

References:

Benedetti M.S., Malnoë A. & Broillet A.L. (1977) "Absorption, metabolism and excretion of safrole in the rat and man." Toxicology 7(1), 69-83.

Bisset N. (1994) “Sassafras lignum.” in Herbal Drugs and Phytopharmaceuticals. Stuttgart, Germany: CRC Press (1994) pp 455–56

Boberg E.W., Miller E.C., Miller J.A., Poland A. & Liem A. (1983) “Strong evidence from studies with brachymorphic mice and pentachlorophenol that 1′-sulfooxysafrole is the major ultimate electrophilic and carcinogenic metabolite of 1′-hydroxysafrole in mouse liver.” Cancer Res. 43, 5163–5173.

Bolton J.L., Acay N.M. & Vukomanovic V. (1994) “Evidence that 4-allyl-o-quinones spontaneously rearrange to their more electrophilic quinone methides: potential bioactivation mechanism for the hepatocarcinogen safrole.” Chem. Res. Toxicol. 7, 443–450.

Choong Y.-M. & Lin H.-J. (2001) “A Rapid and Simple Gas Chromatographic Method for Direct Determination of Safrole in Soft Drinks.” Journal of Food and Drug Analysis 9(1), 27-32.

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

by Tony Burfield, Cropwatch, 6^th Sept 2009

For previous posts on this topic see here and here.

Preamble

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

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

Melissa Oil: Lesson Learned

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

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

Melissa Oil – the Further Details

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

Catherine writes:

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

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

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

Addenda – Analysis Data received from Robertet.

Analysis of Melissa EO sample used in HRIPT test.

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

Information Stat from SAPAD

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

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

Notes and News

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

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

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

Robertet Reveals its Evidence on Melissa Oil to Cropwatch

by Tony Burfield July 2009

You may remember that Cropwatch was quite puzzled by any need for IFRA’s new restrictive Standard for Melissa oil in IFRA’s 44^th Amendment, and had requested details of three unpublished toxicology reports from both RIFM & Robertet, Grasse, which were not available in the public domain, but which were cited by IFRA as containing evidence sufficient to restrict its use in perfumery. The back-story on this matter is available in the Cropwatch Files at http://www.cropwatch.org/Meliissa officinalis - Cropwatch article archive.pdf, but to briefly recap, although Melissa oil & extracts occupy an important place in aromatherapy and herbal medicine, Melissa oil is virtually unused in corporate perfumery. Nevertheless IFRA had previously seen fit to ban it as an ingredient on the basis of undisclosed evidence. There seemed to be no such body of evidence within the RIFM data-base to support such a ban, and it is a complete mystery to many of us how REXPAN could have come to such a conclusion. The ban has now been transformed into a concentration restriction under IFRA’s hyper-bureaucratic QRA system. In the interests of Freedom of Information, Cropwatch has compiled a comprehensive bibliography of the available literature on Melissa oil in the Cropwatch Files section of its website, to enable any interested parties amongst the general public at large to make their own minds up about the need for any restriction.

Although RIFM has ignored Cropwatch’s request for the withheld evidence on Melissa oil as noted above, Catherine Gadras of Robertet, Grasse very kindly responded with a summary of the test data, which is displayed at http://www.cropwatch.org/Melissa EO testing summery.pdf, and offered to answer any further points. Accordingly we asked Robertet (on 14^th June) to accurately define the botanical nomenclature of the Melissa species employed (was it, for example, the oil from Melissa officinalis L. subsp. officinalis?), the geographical origin of the Melissa herbage used to steam distill the essential oil, and the compositions of the oils employed in the research (since commercial Melissa oils vary widely – see Cropwatch’s Melissa oil bibliography). We also asked, in as many words, if the Robertet team would like venture any comments on the fact that there was a complete lack of adverse human reactions in the Robertet HRIPT studies, contrary to the numerical indications of possible sensitiser activity shown by the EC3 value? Without going into too many further details, this data would seem to offer further support as to the flawed ability of the LLNA test to accurately predict sensitiser potency for aromatic ingredients, and its questionable place of this animal-based test within the over-bureaucratic QRA system. But presumably, unless a notable such as Professor Axel Schnuch stands up and gives a paper on perfume ingredients with indicatory EC3 values which do not produce a significant number of adverse reactions per 10,000 dermatitis patients, no action will be taken by IFRA or by the `EU’s ‘expert’ committees to scrap this flawed QRA system (we make this comment since Schnuch’s evidence seems to have contributed to the pressure on the EU Cosmetics Commission to belatedly review the situation regarding notorious 26 Allergens debacle - see Cropwatch Files).

If we receive a further reply from Robertet regarding further details of the toxicological studies on Melissa oil, we will post it in the public interest. We should point out that in asking these questions, we did not mean to place Robertet in an awkward position (Robertet being a Direct Company Member of IFRA). However as Martin Watt noted when presented with the Robertet studies summary recently: “(the data presented)… is all typical in-house testing and certainly NOT suitable for ANY scientific evaluation purposes.” And further: “My key point is that RIFM data is only trade recommendations.  The EU committee is attempting to turn those 'recommendations' into EU law.  So far without success, but they keep trying. Only publicly discrediting that committee and the administrators in the European court will anything change.”

Cropwatch’s feeling is that the IFRA/RIFM/REXPAN conglomerate is struggling: better toxicological facilities & superior expertise in specialized subject areas are available outside the organisation, and this situation together with the fact that people are better informed on toxicological matters is stretching the credibility of many of IFRA’s policies and its decision-making generally. The perfume industry certainly needs a safety organisation to protect its interests – but maybe not this one, which is guilty of over-regulating the industry, and confuses the career interests of its composite toxicologists over and above its function to be a balanced safety policy-making unit for the trade.

Technorati Tags: Melissa officinalis,Melissa,IFRA,Robertet,Martin Watt,RIFM,REXPAN,IFRA 44th Amendment