Showing posts with label ifra. Show all posts
Showing posts with label ifra. Show all posts

Monday, November 15, 2010

Outlaw Perfume Project - A Natural Perfumers Guild Artistic Statement


Anya McCoy here, president of the Natural Perfumers Guild, and I'd like to introduce you to our latest project, Outlaw Perfume.

Soon after I started blogging in 2006, I began to write of the incredibly restrictive and unreasonable "guidelines" of the International Fragrance Association, and the resultant laws from the European Union that effectively killed perfumery.  True, they also ranked some synthetics as "dangerous" (brain disruptions), but the list of naturals, which had been used for centuries without major problems, was overwhelming.  I rarely bother to blog about these issues anymore.  I discovered I was the ONLY perfumer doing so at the time, and it cast a bit of a bitter pall over my blog.  I'd rather be blogging about the beauty and luxury of naturals, so here I am.

I passed the ball on to other bloggers! Nine bloggers will be participating this week, and you can find their links at the end of this post.

They're all insightful, intelligent and passionate about perfumery.  Their readership far outstrips mine, and the Outlaw Perfume project is a great way for them to spread the word about this abomination against natural aromatics. They also get to sample the gorgeous perfumes created by the Natural Perfumers Guild members (disclaimer: I'm the president of the Guild) and offer a giveaway of the Outlaw Perfume on their blogs. 

I've always been someone who challenges authority. In the 60's, I marched for civil rights, against the Vietnam War, and for women's rights.  This IFRA and EU-driven blacklisting agenda against naturals must stop.  Readers, please remember that they're stomping on *your* rights to choose what you put on or in your body.

Anyone can use common sense and not put perfume on skin that is exposed to sunlight, so, there, the photo-sensitization problem of some of the citruses, angelica root, etc., solved ;-)  Think you may be a bit sensitized to oakmoss? Wear the perfume in your hair, or on your clothing, or in a perfume jewelry piece. 

I'm taking photos of vinaigrettes and perfume lockets that I'll share later this week.  They're a beautiful addition to a jewelry wardrobe, and serve a double purpose of gently releasing your perfume. It's all about our choice, and not bowing down to nanny-state governments.  How simple if a warning label, some perfume dabbed in your hair, or on your clothing, or in a piece of pretty jewelry solves this problem.  Or, if you're a daring outlaw like me - wear it on your skin!


The bloggers will be posting their commentaries and reviews Nov. 15 - Nov. 21, 2010.  I'm delighted by the prospect of lively and informed posts by readers.

Participating Perfumers:

http://lordsjester.com
www.bioscent.info
http://anyasgarden.com
www.providenceperfume.com
www.dshperfumes.com
http://tambela.com
http://www.etsy.com/shop/wingandprayerperfume
www.JoAnneBassett.com
http://artemisiaperfume.com

Participating Bloggers:



http://waftbycarol.blogspot.com/
http://www.examiner.com/x-4780-Portland-Fragrance-Examiner
http://fragrancebelleslettres.blogspot.com
http://thenonblonde.blogspot.com/
http://indieperfumes.blogspot.com/
http://cafleurebon.com
http://olfactarama.blogspot.com/
http://perfumeshrine.blogspot.com
http://perfumesmellingthings.blogspot.com

Guild Perfumer's Blogs:

http://providenceperfume.blogspot.com
http://dshnotebook.wordpress.com/
http://lordsjester.wordpress.com
http://aromaticjourneys.blogspot.com

Friday, March 19, 2010

Transcript of Tony Burfield's Presentation on "Is Excessive Regulation Destroying the Perfumery Art?"

Below please find the transcript of the Powerpoint presentation Natural Perfumers Guild Associate Tony Burfield of Cropwatch gave to the British Society of Perfumers March, 2010.

Tony Burfield was the only presenter at the Safety and Regulatory symposium who did not offer ways for the perfumers to comply EFFA, SCCNFP, REACH et al. Instead, he presented fact after scientific fact as to why much of the compliance requirements are based on bad science and political maneuverings, coupled with a dose of market manipulation.

The Natural Perfumers Guild is proud to have Tony as a member and we hope that those reading this will help spread the information presented here. So goes REACH, so go your beloved perfumes.

Tony Burfield's Cropwatch is:

  • A loosely based, non-financed, independent watch-dog to the aroma & natural products trade. In existence approx 6-7 years.
  • Best known for its pro-active campaigning activities on natural aromatics, data-bases on threatened aromatic species & bio-piracy, long-term opposition to the 26 allergens legislation, & to the QRA (which the SCCP has also criticised in SCCP/1153/08).
  • No formal membership; produces an occasional Cropwatch Newsletter which reaches some 40,000 people.
  • Provides free information on natural aromatics on its website www.cropwatch.org and free advice to enquirers.

Part I – Perceived Problems with Fragrance Safety Legislation & Safety ‘Experts’.

Safety Issues in the Aroma Business.

  • Fragrance customers usually insist on adherence to all existing H&S guidelines (both official & voluntary) because of the prevailing fear-culture, and possible media exposure regarding potential adverse effects to end-users from single ‘hazardous’ fragrance ingredients.
  • EU Regulators have no capability of gauging the socio-economic effects of their policies. Banning or restricting natural aromatic materials often has severe economic consequences for natural aromatic producers and dependent communities in developing countries. Disastrous EU legislation is (sometimes) followed by an impact assessment and (then possibly) corrective action – but by then its often too late to save any affected SME’s (e.g. the effect of the BPD on Europe’s natural biocidal product manufacturers).
  • Knowledgeable whistle-blowers revealing questionable trade practices are shunned by the trade (for example, as detailed in the letters of the late Stephan Arctander).
  • 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.
image

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

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

image 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
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.

Part 2. The Mis-regulation of Natural Ingredients – some Examples

Destroying the very foundations of perfumery.

  • The restriction/banning of key fragrance ingredients on dubious / over-precautionary safety grounds, can easily compromise the founding elements of the traditional perfumery art. For instance, the crucially important fougère perfumery accord consists of a combination of bergamot, coumarin & oakmoss.
  • Bergamot oil usage is under threat from potential EU legislation because of its allegedly photo-toxic furocoumarin (FC) content (see flawed SCCP Opinion 0942/05, then compare with the Cropwatch FC data-base).
  • Oakmoss was originally proposed to be restricted as a sensitiser under 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%>
  • 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 <>

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

Wednesday, November 11, 2009

The Evil Stepmother and the Father Who Will Not See - the FDA/GMP is out to perpetuate the eternal scenario


As many of you know, I have fought for years against the creeping corporate takeover of indie and microbusinesses. Just search on this (my Anya's Garden blog) for IFRA, EU, FDA Globalization Act and government. But first, please read the link below, at the end of this blog. The future of our businesses is in immediate danger. I am horrified that several organizations that represent indie and microbusinesses are in lockstep with the FDA and tweeting and blogging about their 'victories" with legislators, either blinded or too blind to see the horrible demise in store for our businesses - they should be fighting the FDA, not kowtowing to it, giddy with "making progress". They're not, they're being fooled.

Please everyone - don't be the frog in the pot of cool water who never feels the heat being turned up until it is too late and he's cooked.

Read this following speech, given at the International Herb Symposium by Stephen Buhner and pass it around, and more importantly, ask those who are all puffed up and happy that the FDA and legislative lackeys of the corporate world that seeks to destroy our businesses why they don't see this coming:

http://www.gaianstudies.org/documents/IHSOPEN.pdf

Tuesday, May 20, 2008

IFRA website redesigned - Easier to find information, harder to use: here is a workaround

The International Fragrance Association (IFRA) has redesigned its website and it has an new look and at first glance seems easier to use, but there are annoying search problems. Since the site is the only place online to find out information on IFRA, the problems can slow down a search. The IFRA website is the repository for all of the information relating to aromatics, both natural and synthetic, according to their own guidelines. The guidelines are not mandatory in the industry, but any association that belongs to IFRA is supposed to promulgate their directives as to what aromatic material is restricted or prohibited. Restricted status means there are limits that the aromatic can be used in either a leave-on or wash-off product, and generally those limits vary according to aromatic and the end use. Prohibited means the aromatic may not be used under any circumstance in a product for the skin.

Now you can search the site either by name, alphabetical listing, CAS number or IFRA Amendment. The main problem with searching the site is that every time you click on a name, an alphabetic link or fill in the blank to search, a pop-up requesting if you wish to "remember that password" appears. Just clicking "not now" is not the solution - the workaround is "never for this site" which will allow you to continue searching unfettered. Not being a member of IFRA, the Guild cannot confirm how this workaround will function if you are an IFRA member, since you need to enter a username and password. The terms "not now" and "never for this site" are for the Firefox browser, your browser may have different language.

For many professional and hobbyist perfumers, frequent visits to the IFRA site are common, because whether in agreement or opposition to the guidelines, it is necessary to be aware of them.

Thursday, May 1, 2008

Cropwatch Asks for your Input



CROPWATCH AT THE CROSSROADS - looking for your feedback

note: if you wish to contact Tony about the questions below, you can write him at info@cropwatch.org

After 4 or 5 years of continuous activity, Cropwatch has some choices to make. Do we go on the way that we have been, snapping at the ankles of those who run & regulate the aroma industry so badly, or should we 'old dogs' learn some new tricks? Cropwatch supporters, and organisations sympathetic to our aims, regularly offer us donations and advise us of potential sources of grants, to which we have always said 'no thanks, we're non-financed'. Our current thinking is that this might be a mistake, since we are limiting our potential effectiveness. .

We are certainly not asking everyone for money, but we are asking you to help us with some feedback on how a financial input could potentially help the aroma world to become a better & fairer place, so please mail us if you have any thoughts or ideas.

Our initial list of ideas to use donated funding would be:

1. To finance risk/benefit studies on natural aromatic products. This research is needed because the existing major players such as IFRA/RIFM, are set up only to investigate the risks/hazards of fragrance ingredients (but not the benefits), & EFFA can only present the safety risks of essential oils, absolutes, resinoids etc in terms of the imagined hazards of the individual contained chemicals, rather than adopting a holistic approach for the aromatic ingredient as a whole. Therefore both organisations are badly positioned to defend natural aromatic ingredients against the current avalanche of restrictive legislation.

The EU Commissioners have previously declined to accept safety-data based on risk/benefit considerations, although we believe this policy to be untenable in the long-term - it is the norm in virtually every other regulatory area (biocides, agricultural chemicals, pharmaceuticals etc).

[Neither is this just a European problem. The U.S. House Committee on Energy and Commerce have just announced draft legislation (Global Harmonisation Act 2008) intended stimulate discussion on how to provide adequate funding and authority for the FDA to ensure the safety of the nation's food, drug, medical device and cosmetic supply in an increasingly globalised marketplace. The draft legislation already highlights several areas which will affect the fragrance industry].

2. To develop statistical data on the adverse effects of restricted & prohibited aromatic materials. This data would be a potential bombshell to blow apart the over-precautionary approaches of the cosmetic regulators and career toxicologists, who are in such a powerful position in global regulatory circles. Where this data exists (e.g. the Schnuch data on alleged allergens) it is already causing red faces. The EU Commissioner has previously indicated to Cropwatch (Brussels 2007) that this type of adverse reaction data is inadmissible as safety evidence. But if you are familiar with English history, you might recall that King Canute failed to hold back the waves and so his followers realised he was not all-powerful. So too, the regulators will not be able to ignore the fact that many restrictions on natural products are based on corporate toxicological constructs which don't manifest in the great numbers of negative health effects predicted.

3. To assist with the growing & production of useful commodities from threatened aromatic plants, for cosmetic, aromatherapeutic, flavour & medicinal outlets, in a way that benefits the poor.

4. To set up or help set up a natural aromatics products professional body, with the help of other interested parties. Already we can identify several sub-divided areas which badly need assistance: natural perfumery, the use of naturals within conventional perfumery, natural biocides, herbal drugs & medicines, aromatherapy, natural cosmetics etc.

5. The lobbying of officials & regulators. As we have seen, the more the establishment closes ranks (and its mind) to contrary & dissenting views, the more popular support we have been able to attract. In terms of numbers we are potentially a powerful force. However we have to ask ourselves whether there is any point in continuing the lobbying game. Many of the points we make go unanswered because the officials involved are not sufficiently technically adept or experienced to even understand the arguments put forward. So is it better to plough ahead with a voluntary regulatory system of our own making - at least we might have the experience, familiarity & resources to do a better job. The enormity of the task is detracting, but this is put more into perspective if sufficient funding were to be available.

6. To keep the flame of our traditional perfumery heritage alight. When we read that several major aroma corporations are training fledgling perfumers in pure synthetic perfumery, it makes us wonder if the world has gone quite mad. Once perfumers used to be creative artists with forthright temperaments, views and opinions, passionate about their art. Now, are we all to be reduced to company drones?

I was related a story recently concerning a certain essential oils salesman who offered unmarked samples of real good quality Bulgarian lavender oil, and a synthetic lavender construct to a group of young perfumers at a certain megacorporation. The group preferred the artificial lavender construct because "it smelled like linalyl acetate, like its supposed to." Heaven help us! But maybe some of us 'old-timers' should organise courses & lectures to pass on the 'ancient knowledge of the art of perfumery' before it is lost forever.

OK, after 5 or so years of trying, we pretty much know what the problems facing us are - what we don't have is a consensus on the best way to solve them. Maybe you can help?
Cropwatch Team

Thursday, April 24, 2008

Press Release: Natural Perfumers Guild and Cropwatch Oppose Limits on Citrus Oil Usage in Perfumery


Proposed Citrus Oil Limits in Perfumery opposed by
The Natural Perfumers Guild and Cropwatch

IFRA proposed citrus oil limits are cultural vandalism on the art of perfumery and are based on bad science, reports NPG and Cropwatch.

For Immediate Release

MIAMI SHORES, Fla./EWORLDWIRE/Apr 24, 2008 --- Cropwatch and the Natural Perfumers Guild have joined to charge The International Fragrance Association with cultural vandalism, claiming the proposed limits to citrus in perfumes will destroy perfumes.

The Natural Perfumers Guild (NPG) and Cropwatch decry the science and proposals of the International Fragrance Association (IFRA) as slanted and overly-restrictive regarding the amounts of furanocoumarins to be permitted in perfume and fragranced products. According to NPG spokesperson Anya McCoy, "We are very disappointed that IFRA have not vigorously defended the use of citrus oil ingredients against pressure from Brussels, specifically the European Union Cosmetics Commission (EUCC)."

"You can get more oil in your hands slicing up a lime or a grapefruit than IFRA wants to allow in perfume or cosmetics with its new proposals," added McCoy."

Furanocoumarins in perfumes and essential oils can cause photosensitization and phototoxicity if incorrectly used by the end wearer, resulting in perhaps a tanning effect to the skin in blotchy areas where applied and not protected against sunlight.

Most pointedly, the furanocoumarins in citrus oils are found by Cropwatch and the NPG to be given such a bad rap by the IFRA, that if perfumers have to limit their use, fresh colognes and citrusy perfumes as they are known will cease to exist. "We believe this to be cultural heritage destruction of the artform of perfumery."

Tony Burfield of Cropwatch has updated the Furanocoumarins A-Z listing in Natural Aromatics. Cropwatch took on the task of constructing this database due to the relative unavailability of such data to essential oil users and perfume formulators. This database aims to provide of accurate information on citrus oil furanocoumarin distribution in raw materials.

Summation of the issue can be found at http://cropwatch.org/citrus%20intro.pdf.

The comprehensive database is available for download at http://cropwatch.org/Furanocoumarins%20A-Z.pdf.

The database expands on information about furanocoumarins - botanical species, variety, geographical region, processing methodology and time of season - which the IFRA previously published in an insufficiently detailed form to be useful.

Burfield added, "Furanocoumarin information is needed in the light of IFRA's proposals, currently set before the European Union (EU) Commission, whereby six major marker furanocoumarins have been identified by IFRA, and it is proposed that their concentration, in any combination, within retailed fragranced cosmetics should not exceed 5ppm for products left on the skin, and 50ppm in wash-off products.

"Such Draconian limits spell the end of the line for natural perfumery in traditional citrus colognes."

The Natural Perfumers Guild and Cropwatch contend that the IFRA and the EUCC don't have the rights to permanently encumber or damage the art of perfumery by denying perfumers the use of traditional citrus ingredients when a labeling solution warning about furanocoumarin risks, such as, "Only wear under heavy clothing," or, "Do not expose fragranced skin to sunlight for 12-24 hours," would easily suffice.

Learn more about the Natural Perfumers Guild at http://www.naturalperfumers.com.

HTML: http://www.eworldwire.com/view_release.php?id=none
PDF: http://www.eworldwire.com/view_release.php?id=none
ONLINE NEWSROOM: http://www.eworldwire.com/newsroom/310315.htm
NEWSROOM RSS FEED: http://newsroom.eworldwire.com/xml/newsrooms/310315.xml
LOGO: http://www.eworldwire.com/newsroom/310315.htm

CONTACT:
Anya McCoy
Natural Perfumers Guild
Miami Shores, FL 33153
PHONE. 305-756-0065
http://www.naturalperfumers.com

KEYWORDS: Natural Perfumers Guild, Cropwatch, Tony Burfield, Mandy Aftel, Anya McCoy, citrus oil limits, International Fragrance Association, perfumery, perfume, IFRA, oppose citrus oil limits in perfumery

SOURCE: Natural Perfumers Guild


Sunday, April 20, 2008

The Natural Perfumers Guild joins Cropwatch in condemning IFRA's "Cultural Vandalism"


Do you love a citrusy cologne? Are you sensible enough to perhaps cover up your skin where the cologne is applied if you receive a warning label on the bottle of perfume that sun exposure may cause blotchiness? Do you detest and resist government interference in your right to choose? Did you know the limits say that you can get more orange oil on your skin peeling the fruit than they will allow in a perfume?

The Natural Perfumers Guild and Cropwatch decry the bad science and bullying tactics of the International Fragrance Association (IFRA) and it's proposed limits to the use of raw aromatics containing amounts of furanocoumarins in amounts IFRA deems unacceptable. We deem it "Cultural Vandalism" of the historic art of perfumery.

There will be a press release on this issue in the next few days but in the meantime please visit Cropwatch for more information. Warning - complex and wonderful detailed offerings from Tony Burfield - the database is 111 pages long!

The Intro (only seven pages) is a wonderful Burfield rant, logical and impassioned - against the illogical and bureaucratic mess that IFRA has once again gotten itself into. The database can be found here.

Protecting the future of availability and freedom of choice regarding natural aromatics, the Natural Perfumers Guild is proud to be associated with as dedicated a scientist as Tony Burfield of Cropwatch.