Tuesday, March 25, 2008
Citrus Oils: the Situation
Cropwatch is directly opposing IFRA's Risk Assessment on furanocoumarins, and its proposals to severely restrict citrus oil usage in cosmetics products. Unfortunately, because of the lack of transparency exercised by RIFM, IFRA and the EU Commission over this matter. it means that unless you, dear reader, belong to a professional association, probably won't get to see IFRA's information letter IL799 on the topic, or the Risk Assessment that the EU Commission was given in late 2007 by IFRA. IFRA have apparently suggested a cosy future chat with the EU Commissioners, some unnamed industry moguls and fragrance consumers (presumably IFRA or RIFM members) to 'explain matters' - presumably code for agreeing their highly restrictive citrus oil proposals (see below) with the EU regulator. Nobody with an independent or contrary opinion is to be invited.
In a nutshell, the alleged photo-carcinogenic & photo-mutagenic effects of furanocoumarins (mainly from citrus ingredients) contained within cosmetic preparations are causing concerns to the cosmetic regulators. The previous proposal with the SCC(NF)P 00329/00 Opinion to limit all furocoumarins & furocoumarin-like substances to 1 ppm has been dismissed on all sides as unworkable, since not all fur(an)ocoumarins are phototoxic, and nobody has a clue about the furanocoumarin content of citrus ingredients they use. Nobody knows either, what "furocoumarin-like substances" are. Similar critical remarks apply to the next stab that the SCCP made at the subject (SCCP 0942/05).
Now IFRA propose to limit any combination of 6 furanocoumarins markers in finished cosmetics, to 5 ppm for leave-on products, and 50 ppm in rinse off products. The 6 furanocoumarin markers are surrogates for the total furanocoumarin content of the cosmetic preparation, and are identified as follows: bergapten, bergamottin, byakangelicol, epoxybergamottin, isopimpinellin & oxypeucedanin.. In other words, the use of citrus oils in alcoholic perfumery is finished. IFRA are proposing to agree an analytical method for furanocoumarin estimation in cosmetic ingredients by Spring 2008. IFRA are also proposing the use of UV-absorbers to counter the phototoxic effects of furanocoumarins, but these are already in use for many categories of cosmetic products.
IFRA-RIFM are busy demonstrating to us all that they know as much about terpene chemistry as they have previously shown they do about botany! In the real world, furanocoumarin concentrations vary in citrus products from zero to several thousand ppm depending on processing, botanical origin down to varietal level, geographical location, growing conditions & history etc. Further, furanocoumarins interconvert & degrade during processing and in the finished cosmetic product, making matters even more complex. IFRA-RIFM have also been essentially dishonest in ignoring the fact that much of the citrus product on the market is adulterated, and they have not discussed the implications of this for furanocoumarin occurrence in citrus ingredients & the toxicological consequences thereof. Luckily the subject is extensively covered in the scientific literature by real experts in the field.
Previous IFRA & RIFM statements (which are often conflicting) on citrus oil photo-toxicity and essential oil composition have been collected in the accompanying data-base document, together with independent findings from workers in the field. This will be progressively updated.
Cropwatch has further collected items on individual furanocoumarins, and on relevant photo-toxicological topics so that (a) we assess whether IFRA-RIFM have properly represented the total available knowledge on the subject, and (b) so we can all follow the arguments presented. This will be progressively updated as well.
Our main conclusion thus far, is that IFRA is not presenting a policy for citrus oils which is in the best interests of the fragrance industry. Rather, it is presenting over-precautionary safety proposal which is in the best interests of toxicologists. Much of the available scientific data available on furanocoumarins is slanted towards so-called 'evidence' from repetitive & relatively extreme medical treatments for serious skin diseases, such as PUVA. There is very little explanation of the relatively low incidence of adverse photo-toxicological effects from furanocoumarin-containing essential oils, the role & interplay of protective & anti-carcinogenic effects of the other components within essential oils, an area which is still little investigated & little understood. The essential oil & fragrance industry has thus been badly served by these developments & could have reasonably expected a vigorous defence of citrus ingredients, not their consignment to the dustbin.
Cropwatch will continue to campaign for a sensible & proportionate policy for citrus ingredients. Cropwatch supporters outnumber the total IFRA, RIFM & EFFA membership combined and from the contacts we had with perfumers, soap-makers, cosmetics manufacturers etc., we believe they will ignore these proposed IFRA restrictions as both unworkable & unnecessary. .
The Cropwatch Team.
STOP THE FDA GLOBALIZATION ACT OF 2008
Thursday, March 20, 2008
My gigantic plant of Jasmine sambac Duke of Tuscany is starting to bloom. This sambac is slow growing and has huge - for jasmine huge I should qualify - flowers about the size of a tiny carnation, full of tightly-packed petals and the most tender non-indolic jasmine scent ever. I just adore it! I just plucked the first blossom of the season from it today, and left one on for the birds and lizards to enjoy ;-) It's full of about-to-open buds, and I hope I have some to bring to the lunch tomorrow of the Miami NP crew so they can enjoy it.
I coined the organoleptic term "tender" and I have to add that to the Aromatic Lexicon on the evaluation sheet my students use. So many of the home-grown jasmines I have become "tender" upon tincturing. Sigh. They're just so lovely, tender, powdery, soft, sweet and delicious.
April and May are the big jasmine blooming months here in Miami, not August and September as they are in India and France. Don't know the reason for that switch in blooming season, but it is what I have observed over years of growing the eight varieties of jasmine on my property. Some vines are much more floriferous than the others, and keep blooming right through summer, like the J. azoricum. My vines have grown tremendously since last year, with no fertilizer. I'm looking forward to a bumper crop of tinctures - it's very exciting!
Friday, March 14, 2008
Monday, March 03, 2008
Additionally, Salaam is the only natural perfumer included in Turin's new book, another great accomplishment. For all the debate that often goes on in internet forums over whether natural perfumes can or cannot "equal" the mostly-synthetic mainstream perfumes on the market today, this recognition goes a long way towards validating our subtle art. Salaam has decades of experience working with the beautiful raw natural aromatics, and his restrained, elegant style of perfumery does allow him to take a place at the pinnacle of natural perfumery. Please don't forget, however, that the new art of natural perfumery is just that - new. There are many natural perfumers that are working towards perfecting their art and many are self-taught, as is Salaam. No school in Grasse offers a course in natural perfumery, no corporate school does either. We're all artisans seeking recognition and acceptance for our hand-crafted perfumes, and his beautiful perfumes are paving the way for this.
At the end of the day, Salaam has conquered the Mount Everest of skeptics, and thus makes the trek to the top of the mountain easier for all of us.
If everyone dashes to Salaam's website they may find perhaps no timely replies. Currently, at least for the next week or two, Salaam is doing his yearly charity mission. This year he is in Timbuktu. Yes, that Timbuktu. He's helping dig and install wells for fresh water. He travels to war-torn or ravaged parts of the world for a few months every winter helping others.
I can think of no member of the Guild to be more proud of, and no member more deserving of such recognition. He's a Muslim, but I hope he understands when I call him a maven and a mensch. And a master perfumer.
Saturday, March 01, 2008
I've known Natural Perfumers Guild member Tony Burfield of Cropwatch for about ten years now. We "met" in online forums on aromatherapy, where we, and many others were real "safety nuts." All this precedes the recent upsurge in interest in niche perfumers creating fragrances in their (often unregulated) studios. At the time we were alarmed at the new folks flooding into the aromatherapy world, enticed with, and in love with, natural aromatics. Often they had no idea of maximum allowable usage rates and surrounding safety issues.
Natural aromatics do have some risk factors, depending upon the chemical composition of the aromatic and the rate at which it is used in a blend. Some are fairly innocuous. Others can permanantly scar you with Berloque dermatitis markings, which look like dark, blotchy birthmarks. Others may cause blistering rashes, itching and lifelong sensitization. A few cause allergenic reactions in the respiratory track, such as sneezing. For example, if you're allergic to roses, you probably shouldn't use a perfume with rose oil in it. Rather basic common sense.
I will state that I believe most of the rhinitis and asthmatic attacks so often written about in the past few decades are not due to natural aromatics, but synthetic molecules created in a lab, from coal tar, that make up the majority of the blend in modern synthetic fragrances. Those who use such synthetic chemicals in perfume have their own fight to wage with IFRA and the EU. Tony Burfield and Kendra Kirkham of Cropwatch and the Guild have taken up the cause for natural aromatics.
This began last year when Tony, Robert Tisserand and myself took it upon ourselves to give up several months of our lives, at a cost of neglecting our income-generating businesses, to write the FAQ and Primer on the proposed 40th Amendment to IFRA's Code of Practice. We just about burned out on the effort, but the results were well worth it.
Please note: All responsible Professional Perfumers I know practice safe perfumery, and most are aware that the limits they place on their art at the recommendations/guidelines of IFRA or the regulations of the EU (if they are under the EU's jurisdication) are just plain bad science. Still, we adhere to limits on orange oil and such because to not do so may cause an actionable lawsuit if someone claimed injury. It has been noted that you get a thousand times the orange oil allowable by IFRA on your hands when you peel an orange, but still, the insurance companies we are with can hold us to those ridiculous IFRA standards.
Tony was invited by the EU to attend a meeting in Brussels in Nov. 2007 (see below.) That was the first-ever recognition of "our side" and Tony wrote about it here.
Please read Tony's latest to see how he finds that bad science is running IFRA's agenda and ruining our perfumes (the last part is my commentary on the situation.) He also calls for further examination of the issue, saying yes, it's a start, but not enough. The Natural Perfumers Guild agrees.
Pre-amble. Cropwatch has been campaigning for a number of years to reverse the “26 allergens” legislation, founded as it is, on “bad science”. We were assured in a face-to-face meeting with the EU Cosmetics Regulator in Brussels in 2007 that this subject would be re-examined, and it appears that this is now the case, as the EU Commission have reportedly agreed to consider the Schnuch evidence (see below). If this is all the evidence on alleged allergens that the Commission is going to review, it will be a disappointment, since further scientific papers on fragrance chemicals originally misclassified as allergens by the SCCNFP (now the SCCP) are piling up, as indicated below.
To recap (Burfield 2008) 26 alleged allergens, 16 occurring in natural complex substances, were identified in SCCNFP Opinion 0329/00 (rubber stamping previous IFRA-RIFM information) and passed into EU legislation under the Directive 2003/15/EC, amending Directive 76/768/EEC. The criteria for the inclusion of these materials as allergens by the SCCP has never been satisfactorily explained. The legislation requires a labeling obligation for finished cosmetic products containing any of the 26 identified allergens present at 0.01% in products rinsed off the skin, or 0.001% in leave-on products.
The Schnuch Evidence (taken from Burfield 2007). The July edition of the German consumer magazine Öko-Test, No. 7/2004, 55, reported on studies done by the IVDK, an information network association of dermatologists, headed up by Prof. Schnuch. It concluded that not all the 26 allergens identified by SCCNFP Opinion, and enshrined in the 7th Amendment to the Cosmetics Act, bear the same risk, and criticises the EU Commission for treating them all as equal. The report classifies allergens accordingly.
Strong potent allergens (I)
Less potent allergens (II)
Rarely found as allergens (III)
Risk of being allergens to small to consider (IV)
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Synthetic fragrance materials also occurring in complex biological substances
isoeugenol, cinnamic aldehyde
benzyl alcohol, benzyl salicylate, geraniol, anisyl alcohol, benzyl benzoate, benzyl cinnamate, citronellol,
d-limonene, linalool, coumarin
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methyl heptine carbonate
amyl cinnamic alcohol, hexyl cinnamic aldehyde, alpha-keton
Table 1. Classification of the ‘26 allergens’ according to IVDK, 2004
The Oko-test report for July 2004 gives details on criteria & an internal ranking system for allergic fragrance ingredients. This penalises the presence of strong allergens (column I above) by two points & penalizes less potent allergens by one point (column II above). Weaker (column III) allergens do not gather points but must be named. Non-allergens (column IV) do not gather points or have to be named.
Schnuch et al. (2007) report in a further study conducted in four periods of six months from Jan 2003 to Dec 2004, on the frequency of sensitisation to the 26 allergens. The authors conducted the patch-testing studies with a large number of consecutive, unselected patients with suspected allergic dermatitis to these 26 compounds. Schnuch et al. concluded that for some of the alleged allergens amongst the 26, neither restriction nor labeling seem justified, and that EU regulators should review the previous decisions taken.
Further Evidence (taken from Burfield 2007). Hostynek & Maibach have critically reviewed the evidence on SCCP alleged allergens, and called into question whether a number of fragrance substances can actually cause allergic contact dermatitis, in a series of articles:
Anisyl alcohol (Hostynek & Maibach 2003a)
Amylcinnamic aldehyde (Hostynek & Maibach 2003b)
Linalool (Hostynek & Maibach 2003c)
Geraniol (Hostynek & Maibach 2004a)
Citronellol (Hostynek & Maibach 2004b)
Alpha-iso-methyl-ionone (Hostynek & Maibach 2004c)
Methyl heptine carbonate (Hostynek & Maibach 2006).
Reviewing the scientific evidence for geraniol, for example, Hostynek & Maibach conclude that they found no cases where a patient had been brought to a clinic directly because of geraniol contact dermatitis. The authors go on to discuss patch-testing mixtures in general, where concentrations of elicitating chemicals are deemed too high, which decreases specificity without greatly affecting sensitivity. Consumers, they argue, may acquire benign allergies after everyday exposure to low doses of geraniol, which are only revealed under patch-testing conditions.
The position of pure coumarin as non-allergen has been extensively reviewed by Cropwatch at http://www.cropwatch.org/Coumarin%20-%20the%20real%20story%20update.pdf Aroma trade associations have tried to belittle the finding that pure coumarin in not an allergen, by stating that the situation of coumarin non-allergy may only apply to (pure) Rhone-Poulenc derived material. However the status of coumarin-containing natural materials, like lavender absolute & tonka bean absolute (previously found non-sensitising by RIFM, remember), is far from clear. Is it safe that finished fragrances containing these coumarin-containing substances as ingredients, have to be labeled to show the presence of allergens, as required under the EU Cosmetics Directive, or not? The EC’s regulations have advanced, but the necessary scientific backing is not there.
Friedrich et al. (2008) looking at a number of monoterpenes using the rat Popliteal Lymph Node Assay (PLNA) concluded that although citral, a-terpinene, b-myrcene and (-)-a-pinene induced a clear immuno-stimulatory response due to their irritant properties, no monoterpene proved to be a sensitizing agent in the PLNA. Further work may reinforce the hypothesis whereby weak irritants such as citral above are often misclassified by techniques such as the LLNA, as weak or moderate sensitizers. Again it underlines the point that we may have been misled by a culture of toxicological imperialism, into forms of precautionary fragrance ingredient legislation which may not ultimately prove to be scientifically robust.
SCCP ‘Out of Touch’.
Although the chairman of the SCCP was quoted as saying words to the effect that he expected the 26 allergens legislation to have little effect on industry, it has lost the industry € millions in labeling & reformulating costs, computer reprogramming costs & lost revenue to natural ingredient producers, as nervous perfume buyers initially demanded the elimination of all allergens from their suppliers’ fragrances, on the basis that by operating this policy, they would escape media attention in the event of any adverse effect complaints about their products. When fragrance houses started offering substandard perfumes as a result of leaving out natural materials containing those dreaded allergens, perfume buyers started to realise that they would have to allow at least some allergens to be present. Although it may not generally realised, a second list of alleged allergens (Frosch et al. 2002) was quickly drawn up by some prominent toxicologists ‘jumping on the bandwagon’ (the authorship team including Ian White, the chairman of the SCCP). This paper included a number of ingredients rarely used in perfumery, and the paper itself was riddled with scientific errors of fact. So this further list of alleged allergens was quietly dropped, following the industry storm that the original 26 allergens legislation created.
Cropwatch believes corporate toxicologists and industry-funded-bodies such as EFFA, are still trying to sneak further allergens into the Cosmetics Directive by the back-door, under the guise of 40th IFRA amendment / QRA methodology. It is difficult to see whose interests they are serving by doing this. Whatever the toxicologists say, the animal-based tests (such as the LLNA) underpinning the science in this area, are not sufficiently robust to use as a basis for further over-hasty legislation.
Curiously industry seems to have no appetite to openly challenge the shaky science frequently supported by those regulatory officers & career toxicologists who seem to have become spokespeople for the entire aroma industry. Yet Cropwatch has, just lately, had a flurry of meeting with top industry officials who worry that cosmetics legislation has now reached such an unnecessary pitch that it is going to destroy the very industry that they have helped create. But since it is the aroma industry which is funding the safety agenda, the answer is quite plain.
Burfield T. (2007) “Over-regulation is Destroying Natural aromatics.” Lecture to the 38th meeting of the ISEO,
Burfield T. (2008) “Regulation of Flavours & Fragrances in
Friedrich K., Delgado I.F., Santos L.M.F., Francisco J.R. Paumgartten J.R.(2007) "Assessment of sensitisation potential of monoterpenes using the rat popliteal lymph node assay" Food & Chem Toxicol 45, 1516-1522.
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.
Hostynek J.J. & Maibach H.I. (2003) “Operational definition of a causative contact allergen – a study with six fragrance allergens.” Exog. Dermatol. 2, 279-285.
Hostynek J.J. & Maibach H.I. (2003a) "Is there evidence that anisyl alcohol causes allergic dermatitis?" Exog. Dermatol. 2, 230-33.
Hostynek J.J. & Maibach H.I. (2003b) "Is there evidence that amylcinnamic aldehyde causes allergic dermatitis?" Exog. Dermatol. 3, 35-46.
Hostynek J.J. & Maibach H.I. (2003c) "Is there evidence that linalool causes allergic dermatitis?" Exog. Dermatol. 2, 223-229.
Hostynek J.J., Maibach H.I. (2004a) “Is there evidence that geraniol causes allergic contact dermatitis?” Exog. Dermatol. 3(6), 318-331.
Hostynek J.J., Maibach H.I. (2004b) “Sensitisaton potential of citronellol” Exog Dermatol 3(6), 307-312.
Hostynek J.J., Maibach H.I. (2004c) “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.
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.