Tony Burfield at Cannes 2010

8/11/2019 Tony Burfield at Cannes 2010

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The Role of Risk Aversion inthe Decline of the Perfumery

Art.

by Tony Burfield,Cropwatch www.cropwatch.org

World Perfumery Congress, Cannes,2nd June 2010 .
http://www.cropwatch.org/http://www.cropwatch.org/


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Hand-cutting lavender in the UK, beforeanybody had heard of the term: acute

contact dermatitis!


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QC lab. in the days before the concept ofHealth & Safety at Work note lighted

cigarettes dangling from lips of staff!


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A bit of history The failure to create a European Fragrance Commission with a brief to

protect & maintain the cultural inheritance and art of European perfumery ,has meant DG-Enterprise & Industry has been relatively free to create aframework of regulatory toxicology for the safety assessment & regulationof fragrances within the Cosmetics industry umbrella. The sale ofcosmetics is primarily regulated under the Cosmetics Directive 76/788/EC,compiled between 1973-5 & adopted in 1976, & successively amended (tobecome supplanted by the new Cosmetics Regulation, to be in force bymid 2013). The approach taken mimicked that for the regulation of foodand pharmaceuticals i.e. is partly based on safety of ingredients and theadoption of lists (Lanuza undated). The outfall from this regulatory

approach has been in the form of ingredient restrictions which have had anegative effect on the art of the possible in perfumery in recent years,thus damaging fragrance creativity & attainments.

Toxicological testing requirements for cosmetics are not specified,although the SCC(NF)P / SCCS expert committee offers opinions (usuallywith the help of carefully selected evidence, spoon-fed by trade-fundedprofessional organisations like EFFA, before its demise) to DG- Entsposed questions on the safety & allergenicity of individual cosmeticingredients. The end result has been a continuing series of amendmentsto the EU Cosmetic Directive limiting the use of aroma ingredients on(often) scientifically contentious, disproportionate & over-precautionarygrounds (see Cropw atch F i les ).

Industry has been openly criticised for its timidity (Durodie 2004) in failingto oppose these regulatory impositions and the attendant bad science,and the underlying culture of toxicological imperialism which drives it.


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SMEs locked out of safety policyconsiderations.

Although a few larger aroma concerns refuse to belong to theprivately-funded IFRA organisation & its affiliates on principle, manySMEs who feel differently often cannot afford the membership fees toprofessional organisations such as RIFM, IFRA, PerfumeManufacturing Organisations etc. which are more suited to thebudgets of the aroma corporates & mega- corporates. These SMEs areeffectively locked out of the health & safety culture.

Yet substantial consumers of natural aromatic materials include the(virtually unregulated) aromatherapy profession, as well as candle-makers / soap-makers/ incense traders / pot pourri makers / hand-made cosmetics makers / general cleaning product makers / naturalperfumers / organic perfume makers all SME's.

In the US, the Colorado State Safe Personal Products Act HB10-48,which included a proposed zero tolerance policy for CMRs incosmetics (with large fines for non-compliance), was defeated in Feb2010 by a small number of SMEs and their advocates, who wrote tothe Colorado Legislature complaining that the act would put them outof business (it is however being re-written for proposed re-introduction, and up to eleven other US States currently have similarbills in the offing). They complained that constantly scrutinisingchanging lists of ingredients put out by authoritative bodies, hiringlegal advisors, and reformulating their products to keep up with thesechanges would force their products costs up, and they would become

uncompetitive and collapse. The situation described above is, ofcourse, similar to that for European SMEs.


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EU Cosmetics Commission Policy. So far, the EU Cosmetics Commission has stuck to a code of

practice where it refuses to measure or quantify individualingredient risks, assess ingredient risk-benefit balanceconsiderations (apart from for preservatives), assess cost-benefitsof risk assessment (if any), clearly relate technical / biological end-point criteria to protection objectives, or consider adverse usereffects data. Over-deployment of the Precautionary Principle canbe counted amongst other short-comings.

Whether this situation may change as a result of the ICCG nowhelping the EU Commission to explore a 2009 initiative by SCHERto promote harmonisation across the SCCS, SCHER and SCENIHRwrt reassessing risk assessment procedures, and the moreeffective communication of risk-related issues, remains to beseen.

[Acronyms: ICCG Inter Committees Coordinating GroupSCHER Scientific Committee on Health &

Environmental Risks SCENIHR Scientific Committee on Emerging &

Newly Identified Health Risks].


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So, its all going according to plan then Ian White (1998): A think tank has been set up consisting of a

balanced representation of dermatologists, fragrance compoundmanufacturers and users (?) to address aspects of the problemsand needs. [Note the absence of independent scientists with theappropriate cross-disciplinary skills] .

According to documents dated 1998 seen by Cropwatch referringto the think tank meetings, DG -Ents requirements were reportedto include (amongst others) a total list of ingredients used infragrances banded by volume, and a simplification of fragrance

ingredient (chemical & botanical) descriptions. IFRA made their 2009 Fragrance Industry Ingredients List (3163substances) public in Jan 2010, compiled as it is from the 2008returns of (an unknown proportion of an unknown number of-)affiliated IFRA members. The list incidentally includes ingredientsnow classified as originating from threatened species, &ingredients that are banned IFRA. Ingredient volume informationis now available from various sources. In Cropwatchs opinion, theseparate COSING/INCI list of cosmetic ingredients demonstratesthe EU Commissions approach to the simplification issuementioned above, via a policy of botanical reductionism (see laterslides) reflecting their lack of expertise in botany & botanicalnomenclature (the latter fact actually admitted to Cropwatch by theEU Commissioner, Brussels, 2007), and additionally in economicbotany.


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SMEs in other areas. In other regulatory areas, economic discrimination against SMEs

remains effectively unaddressed. The EU Commission (The RichMans Club) has long funded its H&S policies by using industry as

a cash-cow, in order to pay for them. For example the high costsof registering & supporting essential oils or natural aromaticextracts as biocides under the Biocidal Products Directive (BPD)98/8/EC, drove the majority of natural biocide companies out of thebusiness. As a result essential oils commonly used as insectrepellents (=biocides) such as citronella, neem & tea tree oils, canno longer be used for this purpose under the BPD exactly the

outcome the synthetic biocides industry wanted. The Traditional Herbal Medicinal Products Directive (THMPD) ECDirective 2004/24/EC seeks to regulate traditional herbal productsused in Ayurveda, Unani & Traditional Chinese Medicines, as wellas in Western traditions. But from 2011, under the likely terms offull implementation of the Directive, products which werepreviously regulated as botanical food supplements will beregulated as if pharmaceuticals, involving high costs forregistration and compliance (and thereby eliminating a largenumber of SMEs involved in the traditional herbal drugs trade). A legal challenge to the Directive from the Allianc e for Natural Heal thInternat ional is underway (now with the support of Chinese &Indian medical group interests see ANH Press Release (2010)); UKMember State ratification at herbal practitioner level is thoughtunlikely as the result of a forthcoming human rights challenge.


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Neem tree Zanzibar (extracts notsupported as permitted EU biocide).


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Traditional herb seller in Sikkim,smiling (as not affected by THMPD!).


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The FDA & the EWG . In the US, the 1938 Food, Drug, and Cosmetic Act was the first Federal

initiative to regulate cosmetics; since then the FDA and industry havecooperated to build a regulatory regime which has a lack of pre-marketsupervision and relies heavily on the self-regulation of industry (slightlyparaphrased from Daum 2006).

But the US cosmetics industry's self-regulatory approach and lack ofingredient safety substantiation has not been without its critics, such asthe increasingly influential environmental organisational groups of theEnviro nm ental Work ing Grou p (EWG), Skin Deep & The Campaign for SafeCos m etics (CSC). According to the EWG website the aim is "to use thepower of public information to protect public health and the environment.

The EWG offer a detailed cosmetic ingredient database on their websitewhich displays comprehensive references to information about researchon specific cosmetic ingredients, but this information lacks objectiveinterpretation, overview or risk analysis of the data contained within any ofthe publications that they cite. This information source, combined witharoma ingredient information from sites such as The Good ScentsCompany , has spawned a new breed of speculative internet healthcommentators, many of whom (it is pretty obvious) have no background inscience or medicine.

The CSCs commissioned report Not So Sexy - The Health Risks of SecretChemicals in Fragrance (CSC 2010) produced by Commonweal,Environmental Working Group, Breast Cancer Fund, Womens Voices forthe Earth & Anne Steinemann (University of Washington), attempts to linkfragrance chemicals with adverse health effects, and has been rebuffed bythe Fragrance Manufacturing Association (FMA 2010) amongst others.Although full of scientific inaccuracy and unsubstantiated innuendo, thereport will add pressure to an already over-regulated industry.


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The Declining Perfumers Palette. As time progresses, the most commonly used fragrance

ingredients in company formulations are increasinglyassociated with hazard & risk coding (as illustrated byOsbiston 2010) and therefore progressive limitations intheir potential range of use.

Vey (2009) maintained that if IFRA didnt introduce theirvoluntary Standards for the fragrance trade, the EUCommission would introduce more draconian regulation.[Cropwatch considers this proposition is pretty doubtful -as illustrated by the initial objection made by EU officialsto putting Rosewood ( A n i b a rosaedora Ducke) into CITESAppendix II (CITES CoP 15 Qatar, March 2010) on the

basis that such a policy couldnt be policed. Thisreveals an underlying situation where the Customs &Excise / H & S / Trading Standards staff of most Europeanmember states are untrained in taxonomic techniquesand forensic analysis. If this dearth of technical abilityamongst enforcement officials is correct, it will be

increasingly unable enforce complex EU cosmetic &general product regulations].


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The Zero -Risk Mindset. (EU) Regulators apply - (o r appear to have b een

pressur i sed in to , by invisible lobbyists ) adisproportionate & excessive degree of regulationwrt aromatic ingredients, which appears to be anattempt to construct a clean, risk-free and largelysynthetic-based safer- than-nature world of their own. That is not the world that most of us wish to inhabit,and Cropwatch believes that many will ignore anyrestrictions which deny us the use of those familiarnatural materials which we associate with our lives,our heritage & our traditions. Tony Burfield (2010).

Absolute reassurance and no -risk policy is howevercontributing to the risk aversity of our society andtriggers biased regulation, which will not deliversubstantial environmental or health benefit.

- Jostman (2007).


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Withdrawal of FragranceIngredients.

Causes: High toxicological testing costs (REACh etc.) means

that many ingredients, are or will be, unable to besupported by producers.

Rising raw material costs are reducing demand forthe more costly aromatic ingredients.

Ingredient hazard & risk coding is making manymaterials increasingly unattractive to employ infragrance formulations.

The situation of progressive ingredient unavailability / withdrawal (especially for naturals) is neither achallenge nor an opportunity to the perfumer - it isan unmitigated disaster - which should bevehemently opposed by anyone who cares about theart of perfumery.


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Derelict vanilla plantation, Seychelles.EU/IFRA policy will repeat similar scenes.


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Old clove distillation works, Zanzibarbefore eugenol was classified as R36-43.Subsequently became twice as derelict!


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Who cares about the restriction offragrance ingredients, & anyway, how

would we ever find out? - Well probably not from the trade press ! Cropwatchs view is thatbecause of existing commercial publishing arrangements (e.g.

between Allured Publishing Corp. & RIFM) many of the industrysleading journals & magazines have failed to address burningissues affecting the fragrance industry because of commercialties. Rather, the impetus has been left to bloggers & fragranceinterest groups on the Internet. Anger & frustration amongstbrand-loyal customer to the reformulation of classic perfumes (e.g.Guerlains Mitsouko see Turin 2007), about which the brandowners themselves are often in-denial, and the constrainingeffects of the IFRA Standards on fragrance creativity felt by Frenchperfumers, have been recently discussed by informedcommentators.

IFRA, and until recently, EFFA (whose fragrance brief has nowbeen transferred to IFRA-Europe), are/were unlikely to petition theEU Commission about the removal of fragrance ingredientrestrictions. This is because the raison d tre of the Commissionis, after all, to continually pass legislation (or they becomepurposeless), and IFRA is engaged on its continual exercise inauthoritative toxicological imperialism (which Cropwatch isconfident will see practically all fragrance ingredients classifiedas hazardous, restricted or banned within a short period).


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The Declining Perfumers Status. Perfumers used to be highly motivated & outspoken

artists, with senior company positions, including boardmembership.

Many of todays perfumers are of declining importance,being merely the obedient manipulators of fragrancelegislation-software, tinkering with formulae to reducelabelling risks, substituting for expensive, withdrawn orhazardous ingredients, and often with a brief tominimise the use of natural materials. After somepossibly unguarded remarks made by aroma companyemployees in the late nineties concerning musks andtheir environmental fate, they are now unable to commentto the media on any current H&S issue (a task taken overby their trade organisations nominated experts), or topublish any material without their employers expresspermission.

In short perfumers have become emasculated and theirprofessional organisations undemocratic - in that theyare not brave enough to openly sympathise or expressthe private views of their members, for fear of upsetting

their masters.


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Creative Limitations due to HazardClassifications of Ingredients.

The Overdose technique (excessive utilisationof a single synthetic ingredient) is under threat.

The citrus FuroCoumarins (FCs) situation -potentially a severe limitation in use ofexpressed citrus oils (bergamot, lemon etc).

Limitation of allowable concentrations of weakrodent carcinogens (methyl eugenol, safrole,methyl chavicol) in natural aromatic ingredients.

The labelling of sensitisers , alleged & otherwise. R50/53 substances allegedly dangerous to the

environment. The fragrant mosses situation, the vanillin

situation, the coumarin situation, the tea treesituation


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The Overdose. Martin Gras as Senior Perfumer at Dragoco, wrote

two important articles (Gras 1990; Gras 1991) onThe Overdose ingredients used in alcoholicperfumery in overdose proportions naming 16ingredients in the first article & 16 in the second(with some repeats in the second).

Gras (1990) commented: Luckily in perfumery, thereare no limits. Few substances are prohibited orrestricted by RIFM or IFRA recommendations. In2010, the above comments made some 20 yearspreviously are no longer valid IFRA standards orhazard / risk labelling codes limit the allowableconcentrations of many of the cited ingredients.


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The Overdose II. Here are a few examples from Martin Grass articles (1990 & 1991): Tonalid to 11% in Fahrenhei t Dior 1968 & 30%) in Tide

Bleach (P&G 1989). Now Xn, N, R22-50/53. Galaxolide 29% Lux Beauty Show er Soap Now N, R50/53. Lyral (HMPCC) 10% in Red Do or (Arden 1989) & 15% in J o o p

(1987). Now Xi, R43, 52/53. Restricted under 44 th IFRAAmendment to 0.02% in QRA Category 1. The restrictions onthis ingredient are having a huge effect on fragrancecomposition in the fine fragrance area.

Lilial (BMHCA) 16% in Eterni ty for Wo m en (Calvin Klein ) ,20% in Calyx (Prescriptive 1986). Now Repr. Carc. Cat. 3, Xn,N, R22,38-43-51/53,62. Restricted under 43 rd IFRAAmendment to 0.1% in QRA Category 1. Similarly therestrictions on this ingredient are having a huge effect onfragrance composition for all types of applications fromhousehold, to detergents to fine fragrance.

Iso E Super 20% in Tresor (Lancme 1990). Now N, R51/53.Restricted under 43 rd IFRA Amendment to 1.34% in QRACategory 1.


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Citrus Oils: a Double Whammy1. . The EC Cosmetics Commissioner wrote to Cropwatch (25.05.2009)

stating that FCs were to be banned in cosmetics except for theirpresence in natural essences. Limits would be fixed via themonitoring of seven marker FCs: bergapten, bergamottin,byakangelicol, epoxybergamottin, isopimpinellin,oxypeucedanin & xanthotoxin. These FCs would be limited to5ppm in leave-on products and 50ppm in rinse-off products. Theanomalous final line Each of the seven FCs should be presentat a level no more than 1ppm invalidates the whole proposal,but has never been withdrawn or corrected.

Drastically limiting FC's in fragranced products would result inthe effective removal of indispensable natural (citrus)ingredients which Cropwatch has described as culturalvandalism against the perfumery art. Fragrance types such asEau de Colognes, Eau Fraiche and citrus-based compositionswould disappear, and chypre & fougre fragrance types which

employ citrus ingredients (especially bergamot oil) in theircharacterising accords would be severely affected.

2. Under DPD/DSD (soon to be under CLP 1272/2008/EC), R50/53environmental labelling (dead fish & tree symbols) has had aserious impact on usage of citrus oils & their terpenes, whichhave been traditionally employed in many types of perfumes for

household & air care products for their diffusion, lift & freshcharacter.


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Citrus Oils II. SCCP Opinion 0942/05 on FCs in cosmetics was, in

Cropwatchs view, a rag -bag of unsubstantiated

assumptions & prejudices, which failed to provideany direct evidence whatsoever of i n v ivo humanphoto-carcinogenicity from citrus FC's.

The SCCPs stated conclusions on photo -carcinogenicity in 0942/05 are at variance with thefindings of other researchers such as Chouroulinkovet al . (1989), Dubertret et al . (1990) & the EMEA(1990).

It remains the case that no single in v i t ro testcurrently exists which can predict the photo-carcinogenicity of FCs. Conversely,photoclastigenocity has been associated with othervery commonly used cosmetic materials such aszinc oxide (Dufour et al . 2006) and titanium dioxide

(Theogaraj et al . 2007).


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Citrus oils III. Most perfumers are unaware of the FC content of the

citrus oil qualities that they use, and their employers donot have, and cannot afford, access to sophisticatedanalytical equipment to determine them; likewise formany small citrus oil producers. In 2007 the CosmeticsCommissioner, Sabine Lecrenier, stated in a mail toCropwatch Furthermore, if a restrictive measurewould be envisaged, a public consultation, via our

website, on economic impact would need to becarried out. that because of this threat of financialdiscrimination, the measure to limit FCs would notgo through . We have seen no further mention of anypublic consultation.

Cropwatch has suggested a labelling solution for the FCproblem by advising users of FC-containing fragrancesto cover up affected skin areas from actinic light for 12-24 hrs. This is already standard practice in thearomatherapy profession, where 0.5 to 2.5% of (citrus)essential oils may be applied to the skin in a bodymassage, and seems to work satisfactorily.

W k R d C i


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Weak Rodent Carcinogens.Restrictions are severely limiting the deployment of naturalaromatic ingredients containing alleged carcinogens, within

fragrance formulations (information below abstracted from IFRA-

IOFI Labelling Manual 2009). This policy is having a negativeimpact on the ability to create spice notes in fragrance formulae.

Substance,Hazard symbol

Found In Risk phrases Carcinogencategory

Mutagencategory

Safrole T Cinnamon leaf,nutmeg, mace,star anise etc..

R45-22-68 2 3

Estragole Xn Basil exotic,tarragon,fennel, staranise etc.

R22-40-43-68 3 3

Methyleugenol Xn

Clove bud, bayWI, pimentoleaf & berry,rose oils,cananga,citronella SriLanka etc.

R22-40-68 3 3

f


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Weak Rodent Carcinogens - Safrole. Safrole T, R45-22-68. Arguably the weakest rodent

carcinogen cited (see 'Safrole: HumanCarcinogenicity Overstated?' in Crop w atch Files ).IFRA limit for safrole + isosafrole + dihydrosafrole inconsumer products is 0.01% (based on conclusionsof Scientific Committee of Cosmetology of the EECSept. 1980; Communication to the EEC Commission

ENV/521/79).Duke (2002): The human carcinogenic potential ofsafrole, if not quite negligible at low doses, isconsiderably less than that of ethanol (Duke 2002).

Cropwatch (2009): The classification of safrole as aCategory 2 human carcinogen and its associationwith risk phrases R22-45-68 seems disproportionateto the risks involved to humans, considering thehistory of human exposure via its occurrence inspices, foodstuffs, beverages, flavourings andfragrances.


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Safrole - dissenting opinion

In the Eastern USA, many sassafras tea drinkersand traditional root beer makers regard the useof natural safrole-containing sassafras flavouringingredients as their inherited cultural right,regarding the 1976 FDA ban as a purely politicaldevice (i.e. to control the movement of safrolewhich is a recreational drug precursor). There isno evidence of an increase in cancers fromsassafras tea-drinking in this part of the US (seeCropwatchs Safrole Bibliography in CropwatchFiles ).


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Allergens - alleged and otherwise. The SCCNFP (Opinions SCCNFP/0017/98 & 0329/00) identified

26 fragrance chemicals (16 of which occur in natural products)associated with a mandatory labelling obligation for allergenswhere the concentration in the final product (where added assuch, or present as part of a natural complex ingredient) is


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Allergens Revisited? The SCCS has recently been asked for an updated scientific opinion on the

mandatory labelling of 26 fragrance substances passed into Annex III of theCosmetics Directive by the 7 th Amendment 2003/15/EC. This was described as aspin-off from the public consultation resulting from the draft form of SCCNFPOpinion SCCNFP/0017/98 and its 1999 conclusion, which divided allergens intotwo groups, 13 frequently reported (List A) well recognised and of mostconcern, & 11 less frequently reported (List B). Two other raw materialfragrance ingredients (oakmoss & treemoss) were also added, making the 26.Demyttenaere (2009) summarised the differences in classification according toSCCNFP Opinion (by reported frequency) against the findings of a study bySchnuch et al (2007), part of a multi-centre project by the IVDK, indicating fivemajor classification contrasts for farnesol, citronellol, benzyl cinnamate, benzylalcohol and benzyl salicylate .

However the tenfold reduction of the concentration of the strong sensitiserisoeugenol in fragrances from 0.2% to 0.02% (1998) by the adherents of IFRAStandards had not reduced the incidence of patch test positivity after 2-3 years(Dillarstone effect); it actually increased in a 5 year study of 3636 subjects in2001-2005 (White et al . 2007), which the authors blamed (but no actual evidencewas cited) on isoeugenol substitution in fragrances, which hydrolyse toisoeugenol. The rise in patch test positivity is true also for other ingredientsincluding Peru balsam (but production volume halved at source since 1982

when IFRA introduced Standards for Peru balsam). The SCCS were asked:

Does the SCCS co nsid er the l is t of al lergens in A nn ex III are the ing redientstha t they shou ld be aware of? Is there a threshold for safe use? Are theresub s tances where processes (ar i s ing f rom m etabol ism , oxidat ion andhyd rolys is ) may lead to cross -reac t iv i ty and n ew a l lergens tha t the publ icsho uld be aware of?


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Allergens what now?Cropwatchs view : No sign then, of an apology for one of sloppiest

episodes in EU regulatory history, where the regulators appear tohave been coerced by easily identifiable lobbyists into passingunnecessary and scientifically unsubstantiated legislation onallergens. It also appears (not for the first time) that individualmembers of the SCC(NF)P have acted as witness, judge & jury inthis matter (see 5 th European Framework Programme FragranceAllergy Contract QLK4-CT-1999-01558). The whole fiasco has costthe trade millions of Euros in relabelling & reformulation costs &depressed essential oil sales for years. No sign either of anyacknowledgement of the body of work by Schnuch, Hostynek &Maibach & others on this topic, who have cast doubt on the trueallergenic status of many of the original 26 listed allergens. The3rd question (previous slide) to the SCCS would presumablyprovide an entre for the work of Hagwall et al . (2008), Hagwall(2009) & others, on the possible metabolism of linalol in-product /in the dermis (critiqued in The trouble with theories about theoxidation of essential oils in the Cropw atch Fi les ). The Hagwallwork is put forward in spite of contrary evidence of the

justification of linalol as an allergen (Hostynek & Maibach 2008).

Conclusions: 1. An independent examination is required for theclinical relevance of fragrance patch testing.

2. As things stand, the SCCS would seem to be in acutedanger of making the same mistakes on this subject all over again.


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Other natural product allergens.Whilst toxicologists & legislators argue over the regulation

of weak allergens, and many of us privately consider

whether they are really weak allergens at all, or justmoderate irritants, the problem allergens in naturalproducts remain largely unrecognised & unconsidered(certainly by RIFM). These include:

Coniferyl benzoate (benzoin Siam; Peru balsam qualities) T-cadinol ( Sch inus mol l e ; ylang-ylang oils) Sesquiterpene lactones (costus qualities; extracts from

plants of the Compositae). Coniferyl alcohol etc.

Cropwatch has been working with some aroma productmanufacturers to attempt to reduce levels of thesepowerful allergens in natural commodities to producesafer products. And whilst there are seemingly unlimitedfunds to help impose regulation because of existinghazardous substances contained within naturalaromatics, there seems to be no available public moneyto look at processing methods which could help reducethese levels.

S b t ll dl D


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Substances allegedly Dangerousfor the Environment.

Pine, fir & spruce needles & other green leaves of plants & trees; roses,stocks, carnations and other flowers; the aerial parts of herbs, brassica

farm crops like rapeseed etc., put millions of tons of volatiles into theatmosphere & soil per annum ( but are not regulated ). In spite of theshown biotoxicity of monoterpene hydrocarbons such as limonene,concentrations of limonene in biota are generally 250 to 20,000 timeslower than the lowest EC50 value (Potter et al. 2005); the authors of thelatter Swedish study concluding at the accumulation of limonene in theenvironment is of minor importance. The R50/53 ingredient labelling

status for limonene is therefore unjustified. Looking at aquatic risk, Herman (2008) concluded fragrance material & its use does not add upto an environmental issue.

By comparison to the volume tree & plant volatile emissions, relativelysmaller amounts of chemicals from aroma industry discharges, greywater from personal care & laundry products, household chemicals &aerosols etc. enter the environment from regulated commodities . Whilstmicrobiological transformation & degradation, photochemical reactionsetc. will eventually metabolise the majority of these aromaticsharmlessly away to carbon dioxide & water, a small number of problemsubstances (e.g. polycyclic musks like HHCB & AHTN found in humanadipose tissue & breast milk) have caused, and continue to cause,concern (Ueno et al 2009). It is likely that these substances accumulatein adults from application of personal care products.

N.B. -Pinene and limonene have both been found in human breast milk.


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Spicy Issues. A large number of essential oils & complex natural products

are classified as R43 sensitising and/or R38 irritant, andtheir use in fragrances has to be restricted to avoidcompulsory labelling. For example ingredients such ascinnamon leaf & clove oils were used to impart spice notesin pot pourris & candles, but R43 issues with cinnamicaldehyde & eugenol contents etc. mean that their use isrestricted.

The classification of methyl eugenol as a rodent carcinogenhas also affected the use of methyl eugenol-containingspice oils in fragrances, such as clove bud, pimento leaf &pimento berry. The relevance of rodent data in predictinghuman carcinogenicity from methyl eugenol has beenquestioned (Robison & Barr 2006).

The classification of safrole as a rodent carcinogen hascurtailed the use of cinnamon leaf & nutmeg oils.

The net effect of these classifications has had a severeimpact on the construction of natural spicy notes intraditional masculine perfumes, particularly for spicyaccords where nutmeg/mace and clove qualities has playeda key role (e.g. mace in Cachare l Pour Hom m e (Cacharel1981).


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Naturals : Are Supplies Running Out? Another factor limiting the perfumers palette is the increasing

demand for natural aromatic ingredients, against a backgroundof limited production capacity, increased internal market usageby producing countries with large populations, such as China &India , rising ingredient costs (including increased fuel andpackaging costs), extremes of climate variability, catastrophicgeophysical events and the general over-exploitation of naturalresources.

So, in spite of rosewood & guaiacwood being passed intoCITES Appendix II (CITES CoP 15, March 2010), many othernatural ingredients face serious over-exploitation. By the timethreatened species are Red Listed by the IUCN or listed in aCITES Appendix, it is often too late to preserve their full geneticdiversity. Current examples: Asian styrax, agarwood oil(various spp.), sandalwood oil East Indian, sandalwood oil East

African ( Osyr i s spp.), Cedrela od orata oil , copaiba balsam,gurjun balsam, candeia plant spp. (used by the Germanpharmaceutical industry as a source of -bisabolol), costusqualities, Parmelia (fragrant lichen) qualities, somefrankincense yielding spp. (e.g. Boswel l i a papyr i fera ),chaulmoogra oil and many others (see Cropwatch A-Z data-base on Threatened Aro m at ic Species ).

Toxicity studies on individual


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Toxicity studies on individualnatural ingredients

welcome to the world of make-believe! Few toxicological studies on natural aromatic ingredients are available

where the source botanical has been expertly identified, batch-tracked, & has been sufficiently evaluated as 100% derived from thenamed botanical. This is true of many of RIFMs toxicologicalassessments of natural ingredients which utilised non-batch trackedindustry-donated commercial materials of unknown purity & origin, &many do not have an associated and sufficiently detailed chemicalanalysis profile to be useful. The majority of these studies can bedismissed as non-scientifically robust.

40-60% of natural aromatic ingredients are adulterated (Cropwatch2009), yet RIFM has yet to carry out a single study on how thiswidespread practice might affect the toxicity of fragrance ingredients.

A number of aromatic ingredients derive from-, or are co-gatheredwith-, more than one botanical species; virtually no formal studiesexist which distinguish how toxicity is affected e.g. co-gatheredJun iperus sab ina berries with J . c o m m u n i s berries to make alcoholicextracts / distilled liquor for gin-making in Central Spain (Casares1964); opoponax from Commiphora Erythrea var. glabrascensEngler (according to IFRA IL 815 ); in practice opoponax is sourced inmarkets and consists of a number of mixed C o m m i p h o r a , and otherspecies.

Reductionism in Botanical Classification


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Reductionism in Botanical Classification.IFRA name /

species cited (if any). INCI name / COSING

perfuming name: speciescited.

Actual species used.

Armoise: Artemisia alba; A.vulgaris - according to IFRA-IOFIlabelling manual 2009 CAS No68991-20-8 (both species). [A.herba alba extract also listedseparately].

COSING: Armoise not listed assuch, but lists Artemisia herba-alba herb oil CAS No: 84775-75-7;Artemisia herba-alba oilINCI: Artemisia herba-alba herb oilleaf oil CAS No: 84775-75-7.

Mainly Artemis ia herba-alba AssoAlso:A. mesatlantica Maire;A. atlantica Cross. Dur.;A. vulgaris L.

Cedarwood oil Chinese. Nobotanical origin cited in IFRA-IOFIlabelling manual CAS No: 8000-27-

9; EINECS-CAS No: 85085-29-6.

COSING: Cupressus funebriswood oil from twigs of Cupressusfunebris. CAS No: 85085-29-6.

Mainly Cupressus funebris Endl.Also Juniperus ch ines is ,J . formosana ,

J. vulgaris .Ho oil (shui). No botanical origincited in IFRA-IOFI labelling manual2009. CAS 8022-27-9; EINECS-CASNo: 91745-89-0.

COSING: Cinnamomum camphoralinalooiferum wood, leaf and rootoils all listed.

Cinnamomum camphora L. var.l inaloolifera Fujita;C. camphora Sieb var. glavescens Hayata.

Litsea cubeba oil Litsea cubeba fruit oil from berriesof Litsea cubeba. CAS No: 68855-

99-2; EINECS-CAS No: 90063-59-6

From several Litsea spp. IncludingLitsea cubeba (Lour) Pers., L.enosma & L. mol l i fo l ia

Chun.

Opoponax qualities from Commiph ora e ry thraea Engl. var.glabrescens Engl. according toIFRA Standards Oct 14th 2009

COSING: Commiphora erythreaEngler var. glabrescens Englergum extract and oil CAS No 93686-00-1INCI: Opoponax oil is the volatileoil obtained from Commiphoraerythrea or related species . CAS8021-36-1; EINECS-CAS: 100084-96-6

Commipho ra e ry threa Engl. var.glabrescens. Also:C, kataf (Forssk) Engl.C. guido tt i Chiov.

C. holt iziana Engl. holt izianaC. pseud opali JB Gillet


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Reductionism in Botanical Classification II. IFRA name /

species cited (if any).INCI name / COSING

perfuming name: speciescited.

Actual species used.

Santolina oil botanical sp. notspecified in IFRA Standard

INCI: Santolina ChamaecyparissusExtract is an extract of the GardenCypress Santolinachamaecyparissus L. AsteraceaeCAS No: 84861-580-

Santolina chamaecypar i ssus L.S. chamaecypar i ssus ssp. incanaS. chamaecypar i ssus ssp.squarosa

S. chamaecypar i ssus ssp. to rmentosa- All produce eos with differentcompos i t i ons

Savin oil Juniperus pho enicea L.according to IFRA-IOFI LabellingManual 2009. CAS No: 68916-94-9.

IFRA Standards: Savin oil shouldnot be used as a fragranceingredient if prepared fromJunperus sabina L. Only oilsprepared from Juniperusphoenicea L. should be used,

Savin oil not listed [Juniperusphoenicea L. wood oil rectified islisted].

Savin oil comes from Juniperussabina L.

Cropwatch maintains that Savin oilhas never been associated with J . phoenicea , which is commonlyknown as Phoenician Juniper.

Linaloe wood oilCAS 8006-86-8. Botanical sp. notspecified in IFRA-IOFI LabellingManual 2009.

Bursera Fagaroides wood oil is anessential oil obtained from woodof the Linaloe, Bursera Fagaroidessyn. (?) B. glabrifilia, B.delpechiana Burseraceae CAS No:

92874-96-9

Bursera aeoxylon (Schneide) Engl.wood and/or berry oil; also fromother Bursera spp. including:B . delphechiana PoissonB. glabrifolia HBKB. s imaruba L.


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Tarred with the same brush.Although no credit was given, the author has been

instrumental in providing evidence to convince the UK & EU

authorities that citronella oil should be placed in Annex I ofthe Directive 91/414/EEC (Plant Protection Products) arguingthat, in contrast to Citronella oil Sri Lanka ( C y m b o p o g o nnardus (L.) Rendle), Citronella oil Java-type ( C y m b o p o g o nwinter ianus Jowitt) has a zero to 0.05% methyl eugenolcontent, and is therefore suitable for use as a cropprotection substance for placing on the market.

Similarly revised safety assessment outcomes potentially existfor -asarone-free calamus oils (EU regulations forkarotypes of Acoru s ca lamu s L. & A. euro paeum for food &beverage use under review), santolina oils from variousSantol ina chamaecypar issus L. subspecies, tagete qualitiesfrom various Tagetes species, and many others.

h


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IFRAs 44 th AmendmentIFRA appeared to have had trouble convincing some of its members

about either the need, or the validity of, a number of the containedStandards in the 44 th Amendment to its CoP.

Vey (2010) publicly apologised for the mistaken banning of melissa oil.Its is now unnecessarily restricted instead (see Robertets test data inCropw atch Fi les ),

Similar concerns about the restriction of estragole have led to somepolicy revisions. The restriction leaves a hole (requirement foringredients with an anisic odour profile) not easily filled by otheringredients (e.g. canthoxal) which may have their own restrictions.

An outcry against the severe restriction of the extremely weak allergenvanillin (an ingredient which could perhaps be added to any update ofMartin Grass Overdose concept), led to the temporary suspension ofthe measure with a pledge of allotting more time in future for industryconsultation to IFRA Standard revisions.

The restriction of benzaldehyde was predictable from a survey ofprevious patch testing publications, but again, leaves a gap in theodour spectrum for (bitter cherry etc) which is difficult to fill.

This comes on top of previous contentious restrictions for atranol &chloroatranol in oakmoss & treemoss qualities, and in other regulatoryareas for coumarin, tea tree oil, peroxides in oils from the Pinaceaeetc. - and many we are still waiting for (especially in regard to FCs incitrus oils).


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Acronyms BPD Biocidal Products Directive (as amended) Directive 98/8/EC CLP Classification, Labelling & Packaging Regulation EC No. CLP 1272/2008 CMR: substance which is Carcinogenic, Mutagenic or Reprotoxic COSING is the European Commission database with information on cosmetic ingredients DG-Ent: Directorate General (Branch of European Commission responsible for Industry) DPD Dangerous Preparation Directive 1999/ 45/EC DSD Dangerous Substances Directive 67/548/EC EMEA European Medicines Evaluation Agency EWG Environmental Working Group FC: FuroCoumarin (syn. FuranoCoumarin)

FDA Food & Drugs Authority (US) ICCG Inter Committees Coordinating Group IFRA International Fragrance Association INCI International Nomenclature of Cosmetic Ingredients QRA Quantitative Risk Assessment RIFM Research Institute for Fragrance Materials SCCNFP Scientific Committee on consumer Products and Non-Food Products SCCP Scientific Committee on consumer Products SCCS Scientific Committee on Consumer Safety SCHER Scientific Committee on Health & Environmental Risks SCENIHR Scientific Committee on Emerging & Newly Identified Health Risks SME Small to Medium-sized Enterprise THMPD Traditional Herbal Medicines Product Directive

R f


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References. ANH Press Release (19 th May 2010): ANH gains positive response following visit to China - see http://www.anh-

europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=email

Casares R. (1964) Juniperus sabina Food Cosmet Toxicolog y 2, 680-681. CSC (2010) see http://safecosmetics.org/article.php?id=644 Chouroulinkov I., Lasne C. & Nguyen- Ba (1989) Study with 5 -MOP, bergamot & Bergasol in mouse skin

carcinogenicity tests. In Psoralens: Past , Present & Future of Photoch emoprotect ion & other biological act ivi t ies .eds: T.B. Fitzpatrick, F. Forlot, M.A. Pathak & F. Urbach pp345-355. John Libby Eurotext. Paris. Daum C.M.L. (2006) Self Regulation in the Cosmetics industry. A necessary reality or a cosmetic illusion?

Submitted paper for Havard Law Degree School 3 rd year course work. Demyttenaere C.R. "Recent EU legislation on flavours & fragrances and its impact on essential oils" in: Baser

K.H.C. & Buchbauer G. eds Handbook of Essential Oils: Science, Technology, and Applications p 923. Dubertret L., Serraf-Tircazes D., Jeanmougin M., Morliere P., Averbeck D. & Young A.R. (1990) Phototoxic properties of perfumes containing bergamot oil on human skin. Photoprotective effect of UVA and UVA

substances. J . Photochem. Photobiol . B: Biology. 7, 251-259. Dufour E.K., Kumaravel T., Nohynek G.J., Kirkland D. & Toutain H. (2006) "Clastogenicity, photoclastogenicity or

pseudo-photo-clastogenicity: Genotoxic effects of zinc oxide in the dark, in preirradiated or simultaneouslyirradiated Chinese hamster ovary cells." Mutat . Re s . 607(2), 215-24.

Durodie B. (2004) The timid corporation why business is terrified of taking risk. Risk Analysis 24(1), 2004 Floch F. (2002) Coumarin in plants and fruits: implications in perfumery. Perf. & Flav. 27 (Mar/Apr 2002), 32-36.

FMA (2010) U.S. Fragrance Association Finds New Cosmetics Report Misleading Fragrance Safety Is No Secret May 13th 2010 http://fmafragrance.org/sub_pages/CSC_release2.pdf

Gras M. (1990) The Overdose Dragoco Report Nov/Dec 1990. Gras M. (1991) The Overdose II talk presented at WPC, May 14 -17, Palma de Mallorrca. Hagvall L., Skld M., Brred-Christensson J., Brje A. & Karlberg A.T. (2008) "Lavender oil lacks natural protection

against autoxidation, forming strong contact allergens on air exposure." Contact Dermat i t is . 59(3), 143-50. Hagvall L. (2009) Formation of s kin sensi t izers f rom fragrance terpenes via oxidat ive act ivat ion routes : Chemical

analysis , s t ructure e lucidat ion PhD Thesis Univers i ty of Gothenberg. Herman S. (2008) A deep breath. see www.stephen-herman.com/085.pdf Hostynek J. & Maibach H. (2008) Allergic contact dermatitis to linalool Perfumer & Flavouris t 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.
http://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://safecosmetics.org/article.php?id=644http://fmafragrance.org/sub_pages/CSC_release2.pdfhttp://fmafragrance.org/sub_pages/CSC_release2.pdfhttp://safecosmetics.org/article.php?id=644http://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=emailhttp://www.anh-europe.org/node/3019?utm_source=The+Alliance+for+Natural+Health&utm_campaign=ab9f7f4046-100519_ANH_eBlast_No_405_19_2010&utm_medium=email


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References contd. Hostynek J.J., Maibach H.I. (2004) Sensitisation 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 Hostynek JJ., Maibach H.J. (2008) Allergic contact dermatitis to linalool. Perf & Flav 33, 52-56. Jostman T. (2007) Precautionary principle for toxic chemicals no alternative to safeguard social

benefits. Human & Exper imental Toxicology 26, 847-849. Lanuza N.T. (undated) Banned Substances in Cosmetic Regulation. The EU example. see

f i l ing.fda.moph.go.th/ l ibrary/e-learning/ .. ./Banned%20Ingredients .ppt Osbiston A. (2010) address to the Safety Symposium, March 2010, British Perfumery Society, Cambridge

Belfrey Hotel, Cambridge (unpublished). Potter A., Andersson J., Sjblom A., Junedahl E., Palm Cousins A., Brorstrm- Lunden (2005) Results

from the Swedish Screening Programme 2004. Part 3 Limonene. IVL (Swedish Environmental ResearchInstitute) Sept 2005.

Robison S.H. & Barr D.B. (2006) The use of biomonitoring data to evaluate methyl eugenol exposure.Envir Health Perspect 114(11), 1797-1801.

Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) Sensitization to 26 fragrances to belabelled according to current European regulation. Results of the IVDK and review of the literature.Contact Dermati t is 57(1),1-10.

Storrs F.J. (2007) Allergen of the year: fragrance. Dermati t is 18(1),3-7 Turin L. (2007) Due Credit NZZ Folio 04/07 . Theogaraj E., Riley S., Hughes L., Maier M., Kirkland D. (2007) "An investigation of the photoclastogenic

potential of ultrafine titanium dioxide particles." Mutat Res. 634(1-2), 205-19. Ueno D. et al . (2009) Synthetic Musk Fragrances in Human Breast Milk and Adipose Tissue from Japan.

Interdisciplinary Studies on Environmental Chemistry - Environmental Research in Asia, Eds., Y.Obayashi, T. Isobe, A. Subramanian, S. Suzuki & S. Tanabe pp. 247 252.

Vey M. (2009) address to the Society of Cosmetic Scientists, Grantham, UK, May 17-19 2009. Vey M. (2010) address to Safety Symposium, British Society of Perfumers, Cambridge Belfrey Hotel, Mar

2010 White I. (1988) Fragrances Future Aspects in Fragrances, Beneficial and Ad verse of Effects ed. P.J.

Documents

Tony Burfield at Cannes 2010