the aromaconnection blog

EFFA’s Citral, Farnesol & Phenylacetaldehyde submission is thrown out by the SCCP

(Being an excerpt from forthcoming Cropwatch Newsletter August 2008)

by Tony Burfield August 2008.

Curiously ignored by the cosmetics trade press, whose hacks probably failed to understand its significance, the Scientific Committee on Cosmetic Products (SCCP) Opinion SCCP/1153/08 on Dermal Sensitisation: Quantitative Risk Assessment (QRA) for Citral, Farnesol and Phenylacetaldehyde (adopted 24^th June 2008) threw out the ‘industry-proposed’ QRA approach for setting safe levels of exposure to citral, farnesol and phenylacetaldehyde in cosmetic products. The Opinion is extensively argued & fairly damning - the SCCP noted that the QRA approach is based on data from experimental sensitisation tests on humans e.g. the Human Repeated Insult Patch Tests (HRIPT) and that model suffers a lack of detailed method description, application experience, is not (yet) validated, and has no strategy to make it so. Epidemiological & experimental data are not integrated into the QRA model; & whereas the model allows for various product categories of exposure, the risks from aggregated exposure (including occupational exposures) are not considered. The SCCP further remark that there is no scientific consensus on the safety factors used. Perhaps most tellingly, the committee consider that safe levels of exposure to existing substances known to cause allergic contact dermatitis in the consumer should be based on clinical data and/or elicitation low-effect levels (Cropwatch comments: as has proven successful for nickel & chromium allergic contact dermatitis). In this light, the required data for citral, farnesol & phenylacetaldehyde was not forthcoming, in spite of a specific request made by Brussels for EFFA to provide it.(all that was provided were a series of model-generated numbers, the relevance of which, in terms of consumer safety, being unknown).

Cropwatch had previously put forward an objection to SCCP ‘expert’ committee over the EFFA submission (of IFRA QRA-based data) on citral, farnesol & phenylacetaldehyde, a copy of which can be seen at http://www.cropwatch.org/objectcitral.pdf. Cropwatch had maintained that this particular submission passed on by EFFA was uniquely important, because it represented first use of the QRA methodology in submissions to the SCCP ‘expert’ committee, to further restrict newly alleged allergens (a process we described as ‘sneaking allergens in by the back-door’). Since the existing classification of allergens under 2003/15/EC has proven so scientifically controversial, it seemed both inappropriate and extremely unwise to legislate to include further allergens in the Cosmetics Directive until the underlying science is better sorted out.

Background

To recap, a considerable head of pressure is building up over the apparent misclassification of a number of fragrance chemicals as allergens under Council Directive 2003/15/EC (the ‘26 allergens’ debacle) which is becoming impossible to ignore. Amongst the highlights of relevance here, you will remember that Storrs (2007) pointed out that the basis for inclusion of fragrance ingredients as allergens has never been defined by the SCCP committee, that Schnuch et al. (2004) have presented evidence showing that an number of fragrance chemicals listed in the ‘26 allergens’ debacle (including citral & farnesol), are rarely found as allergens, and that Sanchez-Politta et al. (2007) had indicated that there was little independent peer-reviewed evidence to support the case showing phenylacetaldehyde as a sensitiser. It is not immediately apparent therefore why EFFA chose to make this QRA-based submission in such an incomplete form, as they must have expected rejection. .

Perhaps at this point we should pause briefly, to explain some procedural theory. The QRA is basically an exposure-based methodology for dermal sensitisation risk assessment, a key component of which is consideration of the dose (of sensitiser) per unit area to determine sensitiser potency. IFRA has expressed its intention to employ this particular methodology "as the core strategy for primary prevention of dermal sensitisation to these materials in consumer products.” Allergic contact dermatitis itself is a skin disease which is classically considered to arise from a series of immunological events, the first being an induction process from a low-molecular weight chemical (for example, a component of an essential oil). Continued exposure to this chemical at a sufficient concentration gives rise to an elicitation process which results in the physical manifestation of the disease. Risk assessment models to predict the potential skin sensitisation potential of fragrance ingredients incorporate three factors: predicted no-effect levels of sensitisation under experimental conditions, an appropriately deemed safety factor, and an exposure assessment. No-effect levels can be derived from predictive tests to determine the sensitisation potency of fragrance ingredients using animal based methodology (as in the Murine Local Lymph Node Assay or LLNA), or by using humans volunteers via the Human Repeated Insult Patch Test (HRIPT). In the HRIPT, fragrance ingredients are tested at ten times the use level on healthy human volunteers – if sensitization occurs, the maximum permitted level is taken as a tenth of the no effect level - but the HRIPT test is now considered an unethical procedure. Results obtained in the LLNA test can be mathematically treated to give an EC3 value (the concentration causing a threefold increase in the lymph node stimulation index) which is obtained by linear interpolation of the LLNA response data; these values being used to give an estimate of sensitiser potency, or to rank contact allergens.

Overall Cropwatch has major concerns over the interpretation of data obtained from these procedures - amongst them are worries that these predictive tests do not sufficiently distinguish between (weak) sensitisers and irritants; that outcomes for single ingredients are highly dependent on test substance purity (which is causing on-going controversy e.g. in the cases of linalool & coumarin), and that, anyway, different animal-based tests (such as rat popliteal lymph node assay or PLNA) yield conflicting results to the LLNA. For example, the LLNA results categorise citral as a low to medium potency sensitiser, whereas Friedrich et al. (2007) found that citral was an irritant & not an immuno- sensitising substance at all, in primary positive PLNA responses.

Regarding the occurrence of the individual fragrance ingredients in question, we explained in our submitted objection detailed above, citral is a mixture of two acyclic monoterpenoids, neral & geranial, which can be regarded as branched chain aliphatic unsaturated aldehydes (cis- and trans-3,7-dimethyl-2,6-octadien-1-al). Citral occurs widely in varying component isomer ratios in many natural products including citrus oils, & concentrated and terpeneless citrus oils such as lemon oil & orange oils, in lemongrass oils, Litsea cubeba oil, black pepper oil, verbena oil, melissa oil, ginger oil, etc. etc. In layman’s terms, most people are regularly exposed to citral in their daily lives e.g. hand exposure occurs when peeling & cutting citrus fruits, and citral is regularly imbibed in the diet as a natural or synthetic flavouring component of some spices and in fruit-based or fruit-flavoured soft drinks.

Farnesol a common sesquiterpene alcohol component of many essential oils, the isomers of which may be typically be found to 4.5% in neroli oil, and to 1% in rose oil. E,E-farnesol also occurs in Santalum spicatum (Australian sandalwood) oils and extracts to 5% (subject to confirmation, IFRA quote to 8%), which distinguishes it from the lower concentrations found in the oil of Santalum album (E.I. Sandalwood). Farnesol is also an impurity in many commercial grades of bisabolol; Cropwatch has recently described [http://www.cropwatch.org/newslet8.pdf] the demise of the Candeia Plant (Eremanthus erythropappus) which was harvested to the point of extinction in the Atlantic Brazilian rainforest to furnish demand from the German pharmaceutical trade for its natural (-)-a-bisabolol content.

Phenylacetaldehyde has a piercing green odor, which on dilution is reminiscent of hyacinths, and is a minor component of many essential oils and fruits – for example it occurs at up to 5% in the headspace of the sweet-pea blossom, Lathyrus odoratus.

Concluding Remarks

To sum up, it remains to be seen whether the SCCP committee will be able to stick to the principles enshrined in their Opinion SCCP/1153/08, in the face of inevitable pressure from industry, and are able to insist that clinical evidence be provided which shows that allergic contact dermatitis is unequivocally linked to exposure effects from specific fragrance chemicals. If they are able to maintain this, and the required forensic examinations of the available clinical & experimental evidence are independently carried out, the list of allergens fulfilling the required allergenic listing criteria could be very short, and the committee will need to reverse their own previous Opinion on allergens & make changes to Directive 2003/15/EC. Meanwhile IFRA plunges even deeper into its predictive QRA-based sensitiser policy, with the announcement of the 43^rd IFRA Amendment (a summary of which will be put out by Cropwatch shortly). Remember, in spite of the pretence of a state of voluntary regulation, IFRA & EFFA members are required to fulfill the requirements of the IFRA CoP to the letter, right or wrong. Overall therefore, the casual observer could be forgiven for thinking that the gulf between toxicological theory/conjecture about sensitisation issues, and the link to robust clinical evidence, is becoming an ever-wider chasm, and we are merely observers in a power-struggle between toxicologists & regulators. Cropwatch pessimistically believes the outcome is inevitable - the regulators salaries depend on the continual passing of new legislation (whether it is appropriate or not) and the data-providing toxicology machine is now the most powerful force in the aroma/cosmetics world. One way or another therefore, aroma ingredients will continue to be restricted & prohibited unnecessarily. The status quo is maintained by the attitude of the fragrance customers, who seem to worry little about whether legislation is either scientifically sound or fair, they just want to know that the fragrance providers are following the current rule-book.

Friedrich K., Delgado I.F., Santos L.M.F., Paumgartten (2007) "Assessment of sensitisation potential of monoterpenes using the rat popliteal lymph node assay." Food & Chemical Toxicology 45 (2007), 1576-1322.

Sanchez-Politta S, Campanelli A, Pashe-Koo F, Saurat JH, Piletta P. (2007) "Allergic contact dermatitis to phenylacetaldehyde: a forgotten allergen?" Contact Dermatitis 56(3),171-2.

Schnuch A., Uter W., Geier J., Lessmann H. & Frosch PJ. (2004) "Contact allergy to farnesol in 2021 consecutively patch tested patients. Results of the IVDK." Contact Dermatitis. 50(3), 117-21. Schnuch A. (2005) 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.

Storrs F.J. (2007) “Allergen of the year: fragrance.” Dermatitis 18(1), 3-7.

Technorati Tags: IFRA,dermal sensitization,dermal sensitisation,QRA. cosmetics ingredients,cosmetic allergens,SCCP,scientific opinion,sensitisation,quantitative risk assessment

UN Numbers for Essential Oils

United Nations (UN) Numbers are four-digit numbers used world-wide in international commerce and transportation to identify hazardous chemicals or classes of hazardous materials.

A friend asked me how to determine what these numbers are for essential oils, since the number is requested on the shipping forms from most shippers. After spending an afternoon researching the question, and realizing that it is rather obscure, I decided to share what I learned with the world.

The prefix UN is followed by 4 numbers ranging from 0000 to 3500,  There are also NA numbers usually starting with 8 or 9 that identify items that haven't been assigned an actual UN number. You may see the 4 digit number on a diamond shaped sign on a tank truck on the highway. Sometimes they are referred to as UN/NA numbers.

The problem with identifying the numbers for essential oils is there isn't a one to one correspondence between a UN number and an essential oil. A number of essential oils may fit into one UN Number. The UN Number is associated with the MSDS sheet for an oil, but there is no requirement to put that number on the MSDS sheet.

In researching this, I determined that there are at least six different numbers that can be assigned to a an essential oil: CAS. IUPAC, EINECS, FEMA, UN, and FDA. There is an effort to develop a Globally Harmonized System (GHS) for all chemicals. But that's another story.

I discovered an Excel spreadsheet on the website of the (US) Office of Hazardous Materials Safety. I downloaded it and analyzed it, but it didn't seem too useful for our purposes, since I could only find about 50 items out of over 3000 that might include an essential oil or an essential oil component. These are the classifications that essential oils fall into. But which ones?

I finally discovered a Word document prepared by EFFA (the European Flavor and Fragrance Association) as an introduction to its 2008 Code of Practice. When I went to the EFFA Home page, lo and behold--a link to this introduction and its 3 Annexes: Attachment 1 for chemicals, Attachment 2 for complex natural substances, and Attachment 3 for potential hazards from complex natural substances. The Attachments are Excel spreadsheets that can be downloaded. 

Right now I leave it to the reader to decipher what all the abbreviations mean.  If you are shipping essential oils, you can use the table in Attachment 2 to look up the UN Number, the Hazard Class, and the Packaging Group.  Then you'll have to follow the instructions of your shipper. Most shippers have training classes available for a nominal fee.

If you want to figure it out for yourself, the packaging rules for the US are included in the Code of Federal Regulations Title 49 Part 173. The HMT spreadsheet from the Office of Hazardous Materials Safety mentioned above tells you which Sections apply. For example, from the EFFA table you can determine that frankincense (called olibanum there) is UN1169, Class 3, Packaging Group III. If you go to the HMT table you will see that UN1169 is Extracts, Aromatic, liquid and for non-bulk shipping you need to go to section 203. The link to that is here. When you get there you can look up other sections by going to the top level and then finding the other section in the contents.

Note that all these regulations (in the US at least) only apply when you are shipping regulated hazardous materials in containers over 1 ounce. There are packaging rules here that you will have to meet for smaller quantities. There may be some other exceptions but I haven't figured them out.

The regulations are complex and figuring them out is difficult.  I hope this information helps you find your way through the jungle.  However, I take no responsibility if you don't get it right.

Technorati Tags: hazardous materials shipping,bulk essential oil shipping,essential oil safety

Essential Oils and Poison Center Reports

A note in the previous post referenced data about poison center reports for essential oils.  This piqued my curiosity, so I read the article in the New York Times and then looked up the original data to gain some perspective.

The NYT article turns out to be an opinion piece based on a book that appears to be part of Big Pharma's attack on natural supplements and natural products. The linked version is rife with corrections that had to be made after publication. The original article was trying to make the case that there were all sorts of "poisonings" that took place from vitamins, supplements, and natural products, and that this was a very bad thing. The corrections begrudgingly pointed out that the data were based on calls to poison centers, and were really about "exposures" and not about actual "poisonings." And they still didn't do a good job of putting it all in a real perspective, failing to mention that half of all poison reports are about pharmaceuticals.

I'm going to focus here on essential oils, which after all are the subject of this blog. Table 22 from the report lists the essential oils (I've omitted details on age, reason, and minor outcomes--look at the full report for that):

Essential oils	No. of Exposures	Adverse Reaction	Treated in Health Care Facility	Outcome Major/Death
Clove oil	446	22	101	0/0
Cinnamon oil	599	29	48	0/0
Eucalyptus oil	522	5	99	3/0
Pennyroyal oil	36	5	14	0/0
Tea tree oil	951	35	151	2/0
Other/unknown	4728	53	406	1/0
Category total	7282	149	819	6/0

Let's put that in perspective--this is out of 2,765,665 total exposures. There were only 6 cases with major outcome and no deaths. In the overall, approximately half of exposures (51%) were for pharmaceuticals, and 49% were non-pharmaceuticals. Essential oil exposures were about .0000263% of all the exposures.  Or for more perspective, there were 17,725 exposures to Soap, with 329 adverse reactions, 5 major outcomes, and no deaths. Perfume got 16,495 exposures, and there was actually 1 death.

The vast majority of EO exposures were to children under the age of six (5422 or 75%) with a smaller number (537) to older children and 1239 to adults. There is a good reason why we put a warning on the bottles about keeping out of reach of children, but I guess some people don't heed it.

The EO's broken out in the listing are probably the most common ones available and are sold in most pharmacies for a variety of uses. It would be unfair to assume that they are the most dangerous.

Just for drill, I looked at the 2006 annual report and it had similar data, with the total number of EO exposures rising slightly to 7377.

The problem with these data is that they are only the exposures actually reported, and in order to calculate the true risk we need to know the number of users. Ideally it would be good to be able to refer to the risk per 1000 users and compare it to other substances similarly. However, since we can only estimate the number of users, and there are no data here, we are just guessing.

The comparison to soap may be useful.  Everyone (well, almost) uses soap and has it available where it can probably be reached by children. If essential oils are just as safe as soap, then the roughly double exposure would suggest that half of people have essential oils in their home.  Since that probably isn't true, then we can assume that essential oils are less safe than soap.

The main thing we can conclude from these data is that we should keep essential oils out of the reach of children, and that they haven't caused any deaths.

Technorati Tags: essential oils,poison center reports,essential oil safety

Pine Oil Tick and Mosquito Repellent

In one of those strange serendipitous moments that can happen with Google Alerts, I visited an article entitled "Tick and Mosquito Repellent Can Be Made Commercially from Pine Oil" which describes "a naturally-occurring compound prepared from pine oil" that deters mosquito biting and repels ticks.

After I read the press release, which contains the curious statement

Some segments of the public perceive efficient synthetic active ingredients as somehow more dangerous than botanical compounds, giving additional importance to the discovery of plant-based isolongifolenone.

my interest was piqued , so I read the patent which has been issued covering the preparation of the compound and "its use in repelling arthropods". Would this product meet the requirements of the NPA Natural Products standard? Would it meet the requirements of the NIRC definition of "Natural"? It's been over 40 years since I had my last chemistry course, but I think I can figure this out.

Reading through the patent, some interesting facts are revealed. Deet has long been considered the standard for mosquito repellency,

However, Deet is a plasticizer and clinical literature reports the association of Deet with neurotoxicity in humans (Robbins, P. J., and M. G. Cherniack. J. Toxicol. Environ. Health, 18: 503-525 (1986)). Thus, there is a great need for effective alternatives to Deet.

Essentially the process of producing takes isolongifolene, which is a naturally occurring component of Pinus longifolia, and converts it to isolongifolenone, which is also naturally occurring in smaller quantities. This is done via oxidation with tert-butyl hydroperoxide in the presence of a catalyst chromium hexacarbonyl. The process has a high yield but may not meet the natural standard because benzene is used to recover the catalyst (which itself is a considered toxic).

According to Wikipedia

In common with many of the other homoleptic metal carbonyls (e.g. nickel carbonyl and iron carbonyl), chromium hexacarbonyl is toxic and thought to be carcinogenic.

Tert-butyl hydroperoxide doesn't have its own entry in Wikipedia, but a search of the ToxSeek database reveals 143 entries.  Without detailed analysis, one can only conclude that it is a toxic hazard.

NPA moves ahead with its "Natural" Product Seal

The Natural Products Association (NPA) has announced that applications for its "Natural Standard" certification are available. The certification process will be based on the NPA Standard published on May 1 [PDF] and discussed here previously (which is not quite ready for prime time, in this reviewer's opinion). Certification will cost $500 per product for members of the NPA, and $1,250 for non-members. The standard requires that labeled products must be made with at least 95% all natural ingredients.

Since the NPA's membership fees for suppliers are not posted on their website, it's difficult to determine what impact this will have on small suppliers who would like to use the seal.  Since the public seems to be more aware of the "Organic" designation, and there are two competing seal programs (OASIS and NSF/ANSI) out there, it may turn out that there isn't even a place for a natural products standard and certification program.  There have been other attempts to define "natural" products, notably the Natural Ingredients Resource Center (NIRC) and the Campaign for Safe Cosmetics (CFSC). The problem with all of these is that they tend to define "Natural" (a positive) by stating what isn't natural (a negative definition).

The NPA definition of "Natural" from their May 1 version of the standard is:

Ingredients that come or are made from a renewable resource found in nature (Flora, Fauna, Mineral), with absolutely no petroleum compounds.

The NPA goes on in their draft standard to specifically list allowed and prohibited ingredients (although the natural ingredients are on an attached list that doesn't seem to be attached) and then has an "Illustrative List of Allowed Ecological Processes".

This contrasts with the NIRC definition (partially quoted):

Natural Ingredients include  plant, animal, mineral or microbial ingredients...

• present in or produced by nature.

• produced using minimal physical processing.*

• directly extracted using simple methods, simple chemical reactions or resulting from naturally occurring biological processes.*

Neither of these definitions really have much "meat" compared to the definitions included in the "real" standards that have been proposed (OASIS & ANSI/NSF Organic Standards), both of which have over 60 definitions of terms that need to be precise so people know what the standard really means.

The "Natural" standard process has not been transparent and subject to the scrutiny that it needs to be subjected to. Moving ahead with it before it has been vetted by the industry and consumers is definitely not in the best interest of either. There has been some discussion of these issues in closed mailing lists, but that does little to force the NCA to open up the process and produce a real standard that has some meaning and can work effectively.

For more information, an article in the June Perfumer&Flavorist discusses "The Case for Natural Personal Care Standards." (Sorry, they make you pay for it.) Although the article contains some misinformation, it is a generally good overview of the state of standards issues as it stood before the Natural Beauty Summit.

Technorati Tags: natural products,definition of natural,NCA,NIRC,natural standards

Is This The End of The Indie Beauty Products Boom as We Know It?

The past decade has seen an explosion of small, independent aromatics products companies emerge from the kitchens and basements of America.  From aromatherapy wellness products creators, indie natural perfumers,  sultry incense  formulators,  handmade soap makers and makers of bath products galore - creative entrepreneurs have conjured up myriad offerings from bath fizzies to sugar scrubs to pampering spa products. 

Then, along came the Food and Drug Administration Globalization Act of 2008, announced last month, proposing to give the FDA authority to affect new regulations that could stop the growth of this creative movement dead in its tracks.  For some, it could be the end.  Under the new rules proposed, The FDA could mandate an annual registration fee of no less than $2,000 (possibly more) per manufacturing facility.  This could put some out of business.    

The Personal Care Products Council (formerly the Cosmetic, Toiletry and Fragrance Association), has already testified before the House Committee on Energy and Commerce, outlining the self-regulatory efforts of the major cosmetic industry over the past several decades.  From the written testimony of Pamela G. Bailey, CFO and President of the PCPC,   "The result of manufacturer safety practices and voluntary initiatives under a existing framework of Federal law has been an outstanding safety record that has been commended by previous FDA Commissioners.  Cosmetics and personal care products are the safest category of products regulated by the FDA."  Stephen F. Sundlof, D.V.M., Ph.D., Center for Food Safety and Applied Nutrition, also submitted testimony which included the following:  "We believe the proposed legislation should be more closely targeted and prioritized according to risk. Several of the legislative sections appear not to be sufficiently focused on high-risk products. Some of these requirements would divert resources, which could detract from important product safety and security priorities."   While these larger entities are not arguing for or against the proposed legislation, these seem to be cautionary statements that would lead us to believe the larger industry has faith in existing industry efforts to self-regulate cosmetic safety via the CIR (Cosmetic Ingredient Review) established by CFTA in 1976 and funded entirely by the industry, evaluating more than 1,300 ingredients and publishing peer-reviewed scientific literature, available to the public. 

We are fortunate to have Donnamaria Coles Johnson who because of her passion for cosmetics and beauty products has tirelessly championed for small beauty products companies.  If you are a small cosmetic manufacturer and are not a member of the Indie Beauty Network, you are missing a plethora of ideas, education and networking to assist your business development.  Donnamaria has put up a public page to address this latest FDA issue, open to the public for comments and suggestions.   She will be preparing a position paper, using members' comments that will carry our voice to be heard by the Committees in charge of vetting public comments.  You can find Donnamaria's message and governmental links here:  http://www.indiebusinessforum.com/forumdisplay.php?f=41 

We urge all small natural cosmetic manufacturers to keep abreast of this issue and join efforts as needed to make sure that indie business doesn't get left behind.     

Cropwatch at the Cross-Roads

Cropwatch Statement

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 to 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

Technorati Tags: Cropwatch,natural aromatic products,perfumery,natural perfumery

Furanocoumarins in Cosmetics: What’s all the Fuss About?

Copyright © Tony Burfield April 2008 

Preamble 

The EU Cosmetics Commission, well known for setting the pace worldwide for
(over-)-precautionary cosmetics legislation, is seemingly determined to limit furanocoumarins (FC’s) in retailed fragranced products to minutely low levels. This is because they consider that these materials present a potential photomutagenic & photocarcinogenic risk to users, when products containing these items are applied to the skin and subsequently exposed to sunlight. The IFRA proposals to limit FC’s in such products are being opposed by Cropwatch amongst others. Cropwatch favour no furanocoumarin restrictions for aroma ingredients, but propose reliance on an alternative warning label solution (‘only wear under heavy clothing’ or ‘if applied to the skin, do not expose to sunlight for 12-24h’). Major sources of FC’s in fragrances are citrus oils, especially cold-pressed citrus oils, and FC’s are especially prevalent in lemon, grapefruit, lime & bergamot qualities. We are also exposed to furanocoumarins from vegetables & fruit in the diet, which may also slightly increase our chances of developing adverse outcomes such as melanoma after sunlight exposure, or which may interfere with the metabolism of prescribed drugs (e.g. from consumption of grapefruit juice etc.). However, as we have learned, because of the way that the EU legislature is set-up & advised, more stringent precautionary legislation applies to cosmetics within the EU than it ever does for foodstuffs. 

Cropwatch FC Data-Base 

Because of the lack of accurate information on FC’s in aromatic raw material ingredients, Cropwatch has extensively updated its Furanocoumarins A-Z listing in Natural Aromatics (the latest update can be seen at http://www.cropwatch.org/FC A-Z.pdf). Cropwatch took on the task of constructing this data-base because of the relative unavailability of accurate information on citrus oil furanocoumarin distribution to essential oil users and to perfume formulators. As can be checked from the data-base, the information on furanocoumarins which IFRA/RIFM has previously published,  is often insufficiently detailed (in terms of botanical species, variety, geographical region, processing methodology and time of season) to be particularly useful. Cropwatch has also included its previous notes on the importance of citrus ingredients to the perfumery art, and also presents notes & references on photo-toxicological topics, as well as notes on individual FC’s and their occurrence in natural products.

The information on furanocoumarin concentrations within citrus & other aroma ingredients is needed in the light of IFRA's proposals, currently set before the 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. Although IFRA's proposals are slightly less severe than the previous blanket proposal by the SCCP to limit all furanocoumarins (whether phototoxic or not) & furanocoumarin-like substances (nobody knows what this definition means!) to 1ppm in cosmetic products across the board, they are still unworkable. In particular the FC proposals spell the end of the line for natural perfumery, as exemplified in traditional citrus colognes, chypres, fougeres etc. Eighty to ninety percent of male fragrances (and a smaller percentage of female fragrances) also contain citrus oils, and so will be severely affected also. But, since DG-Ent/SCCP has a history of rubber-stamping IFRA policy, it can only be assumed that EU legislation will eventually reflect IFRA’s proposals. However, Cropwatch has learned that many cosmetic companies are sufficiently brave and independent-thoughted enough to plan to simply ignore any rulings on future furanocoumarin limitation. 

As can be verified from the data-base, the degree of risk associated with the phototoxicity/photocarcinogenicity of furanocoumarin-containing essential oils, such as cold-pressed bergamot oil, has never been universally agreed amongst toxicologists & dermatologists, over the past several decades. Slightly modifying a passage from the data-base might be illuminating here. In 1988, Young et al. found that a bergapten induced tan is protective against the DNA-damaging effects of solar radiation (bergapten is a major FC in bitter orange, grapefruit, bergamot & other citrus peel oils). Following the finding that the use of bergapten applied in sunscreen enhanced the body’s natural protection for several weeks, even when the sunscreen plus bergapten use was discontinued, funds were provided by the Cancer Research Campaign & Laboratoires Bergaderm to develop a lotion to improve the body’s natural defences (Anon 1992). This product, believed to contain some 30ppm bergapten, was eventually trialed as reported in the media (Hunt 1992). However worries about the furanocoumarin photocarcinogenicity led the EC to order Laboratoires Bergaderm not to release their bergapten-containing Bergasol product onto the market past July 1996 (Goldemberg 1996), eventually forcing Laboratoires Bergaderm into liquidation. It is very difficult for Cropwatch to predict whether, on balance, this EC action subsequently caused deaths or saved lives. What it does illustrate is the rising power of non-technical, non-elected bureaucrats, who are even prepared to act in areas where there is not a 100% consensus of scientific opinion, against the policies of bodies like the Cancer Research Campaign (for references see the A-Z listing). [Thanks to Martin Watt for supplying articles verifying this story]. 

To recap the inadequate state of knowledge that we have on FC’s, the full range of identities of FC’s within many individual citrus & other essential oils (e.g. angelica & cumin) is still incomplete. The properties & phototoxic effects of individual furanocoumarins too are largely unknown, as very pure samples of the materials have been difficult or impossible for toxicologists to obtain. The mutual interactions of substituted coumarins & furanocoumarins within essential oils, their actions when applied to biological systems (the skin) remain virtually unexplored. Risk/benefit considerations of complex biological substances containing furanocoumarins are hardly touched on, and are unlikely to be since RIFM is only geared to evaluate risk, and the Cosmetics Commission still lives in the Dark Ages as it will not accept risk/benefit evaluations (although it will have to eventually). Further, three recent papers on the (pseudo)photo-plastogenicity of cosmetic ingredients (titanium dioxide, zinc oxide) highlight the fact that the methodology of these in vitro studies are seriously flawed – so much so that one group of researchers (Lynch et al. 2008 – see the data-base!) has called for an urgent review of phototoxicity testing techniques as applied to cosmetic materials. Yet, despite these fundamental detractions, some unseen hand appears to be cracking the whip over the EU Commissioners heads, who in turn appear to be exerting pressure on industry for answers & progress. But the science simply isn't there to justify any hasty and ill-conceived legislation on these matters. We don't even know how therapies involving furanocoumarins, such as PUVA, actually work. 

End Thoughts 

In summary, proposals to severely limit furanocoumarins in cosmetic products to such proposed minute levels mentioned above will prohibit the effective use of many citrus oil ingredients within fragrances. Many of us will see this eventuality as an act of cultural vandalism, and we known that many MEP's at Brussels, too, are concerned at the way the Cosmetics Commissioners are systematically wrecking our cultural heritage of high-art perfumery. Enough is enough. It is not the brief of the EU Cosmetics Commission to permanently damage the art of perfumery by denying perfumers the use of 'un-messed about' citrus ingredients, 

Cropwatch wishes to thank those who have contributed, and are continuing to contribute, information to the furanocoumarins data-base. Updates to the data-base will continue to be issued.

Tony Burfield for Cropwatch

Technorati Tags: furanocoumarins,fragrance,furanocoumarin,Cropwatch,citrus oils,EU Cosmetics Commission,IFRA

Comment: The QRA – Quandaries, Reflections & Updates

Copyright © Tony Burfield April 2008. 

QRA – A Potted History 

The Qualitative Risk Assessment (QRA) methodology was recommended as a result of progress of the COLIPA Toxicology Advisory Group and the Joint COLIPA/AISE/EFFA/IFRA Perfume Safety Group, to address dermal sensitisation risk assessment for fragrance ingredients. IFRA adopted this corporate-science derived approach for contact allergens in 2005, when we were informed it was a risk management strategy designed to combat the occurrence of consumer dermal sensitisation, via the restriction of these ingredients in fragranced cosmetic products. This exposure-based system was to be applied across a number of product types grouped into 11 product categories of products (1 to 9 being cosmetic products), setting the concentration limits of individual sensitisers to 'safe levels' for each product category. 

Thus for skin contact, dose per unit area and other considerations could be of primary importance in helping set safe levels of dermal allergens. Information on the QRA system is comprehensively set out in great detail on the IFRA website. The first QRA standards were published by IFRA in May 2006, as part of the 40th IFRA Amendment, and we were told that QRA methodology could be used to set IFRA standards for materials identified as dermal sensitisers where no standards previously existed, or to review the existing IFRA standards. For a while, the old IFRA Standard system would be maintained, whilst industry was getting used to the new QRA system, and making computer reprogramming adjustments etc. 

The first four trialed sensitisers chosen under the QRA system were citral, farnesol, phenylacetaldehyde and tea leaf absolute. EFFA submitted data to the SCCP on citral, farnesol & phenylacetaldehyde, apparently by invitation from the SCCP, who said they needed sensitivity data on IFRA restricted materials to include them in Annex III of the Cosmetics Directive. At the time IFRA restrictions for citral & phenylacetaldehyde were listed in the Inventory part II with quenching proviso’s, but un-noted by the SCCP, IFRA had quietly ditched support for the quenching phenomena (see Cropwatch Review on this topic at http://www.cropwatch.org/newslet8.pdf). Thus the limits for citral under the QRA – IFRA’s 40th Amendment become:

Category	Products	Limit
1	Lip Products, Toys, Insect Repellents	0.04%
2	Deodorants/Antiperspirants	0.05%
3	Hydroalcoholic Products for Shaved Skin, Eye Products, Men’s Facial Cream & Balms, Tampons	0.2%
4	Hydroalcoholic Products for Unshaved Skin, Hair Styling Aids & Sprays, Body Creams]	0.6%
5	Women’s Facial Cream/Facial Make-Up, Hand Cream, Facial masks	0.3%
6	Mouthwash, Toothpaste	1%
7	Intimate Wipes, Baby Wipes	0.1%
8	Make-up Remover, Hair Styling Aids Non-Spray, Nail Care	1.4%
9	Shampoo, Rinse-off Conditioners, Bar Soap, Feminine Hygiene Pads & Liners	5%
10	Detergents, Hard Surface Cleaners, Diapers	2.5%
11	All Non-Skin or Incidental Skin Contact Products	No restriction

Citral distribution amongst some common essential oils is given in IFRA’s 40^th Amendment Appendix 1 Part 1, where you will find values ranging from <90% for lemongrass oils to <0.1% for orange oil sweet (as usual with IFRA, botanical details & geographical origin details are not provided). Similarly, data is presented for farnesol distribution in some natural products.

A pity too, that before EFFA forwarded IFRA’s evidence to the SCCP, they didn’t consider the work of Sanchez-Politta et al. (2007) which indicates that there is little independent peer-reviewed evidence to actually support the classification of phenylacetaldehyde as a sensitiser. It has to be asked therefore, who’s interests are being served here? Certainly not the fragrance industry or the consumer’s. 

Taken overall, we don’t understand why the EU Commission seemingly has a vested interest in furthering the QRA approach, since not all toxicologists support its rationale, and the results from the various animal test protocols which can be used to calculate the EC3 values to predict likely sensitiser potency classifications are often conflicting, such that Dean et al. (2001) correctly surmised that the LLNA test would not correctly identify weak sensitisers or all strong irritants. Further there is very little in the way of aggregate exposure data to support the toxicology, and what there is seems to contradict the predicted classification of sensitizer potency. It is quite possible, from what we have seen so far of the workings of the Cosmetics Commission, that Commission staff themselves are largely are unaware of any other arguments on this subject. Therefore Cropwatch objected to the Regulator (see http://www.cropwatch.org/objectcitral.pdf) that this first use of the QRA methodology did not follow the correct Rules of Legal Procedure Re: Requests for SCCP Opinions in relation to Risk Assessment (C7 2004 D/370235), but we were over-ruled. We also repeated the Storrs argument (Storrs 2007) that DG-Ent/SCCP need to clearly set out & review the basis on which fragrance chemicals have previously been classified as allergens under Directive 2003/15/EC, amending Directive 76/768/EEC, before embarking on any further restrictions (e.g. for citral, farnesol & phenylacetaldehyde). Since only 5 allergens are confirmed as having been the direct cause of clinical allergy, a review of the situation seems imperative. This crucial point has been lost, but Cropwatch predicts, will come back to haunt them, as the rubber-stamping of IFRA's previous opinions on allergens by the SCCP was demonstrably unsafe, as is pretty-well universally acknowledged in the trade. 

In May 2007, the 42nd IFRA Amendment was introduced, to enable the QRA system to be used as a basis to review & redefine IFRA standards set on the basis of dermal sensitisation (16 standards) plus 14 new standards. These were said to cover most of the chemicals currently involved in allergen labeling. Further, as some of these new IFRA standards include ingredients that are present in essential oils and extracts, so these ingredients will also be affected. 

Cropwatch Responds To Bullying

The level of bureaucracy required to enact the QRA approach required that unless perfumes were designed hand-in-hand with software package (such as Formpack), perfumers & formulators would be unable to keep up with the level of calculations required to determine the allowable levels of sensitizers. In early 2007 (15th Jan) Cropwatch started a petition against & announced a boycott of the IFRA 40th Amendment, pointing out that the QRA was creating a hostile environment for the aroma trade, and that the effects of the QRA approach would effectively favour synthetics at the expense of natural aromatics. Cropwatch also alleged discrimination against SME's, since the implementation of this complex approach would make enormously demands on the scarce resources of both small- & micro-organisations. To date, the petition mentioned above has been signed by more than 950, perfumers, natural perfumers, soap-makers, essential oil producers, distributors & users (see http://www.ipetitions.com/petition/ifra40/signatures-20.html), and the petition was eventually presented to IFRA in mid-2007. IFRA did not even have the courtesy to acknowledge receipt of the petition, or to respond in any way, reflecting (in my opinion) the contempt it holds for those who disagree with them. 

Before this, P&F now had started to run a web-poll for votes for and against the QRA issue (see http://www.perfumerflavorist.com/newsletter/5326381.html), and Cropwatch with its massive support from the natural perfumery, essential-oil-using-, soap-making & crafting sectors quickly overwhelmed the poll. Because IFRA was losing heavily (85.1%-14.9%), Jean-Paul Henri, IFRA Director-General, called foul and publicly rapped Jeb Gleason (P&F editor) over the knuckles, so that a grovelling note from Gleason subsequently appeared together with  an accompanying  mail  from Houri (see http://www.perfumerflavorist.com/newsletter/5957641.html). Poll results disappeared from the website & Cropwatch was not invited to put their side of the story - thus history was re-written. In spite of Cropwatch's considerable influence in the perfumery sector, P&F have never printed a single word about Cropwatch activities since (so much for the notion of a free aroma trade press). Louise Prance ran an article on 2nd Mar 2007 for Cosmetics-Design Europe, independently taking the Cropwatch theme that IFRA (exclusively) promotes synthetic ingredients in fragrances, which was hastily taken down, re-written and put-up again, following an objection by Jean-Pierre Houri (Cropwatch has both versions of the article on file). Private correspondence between Houri & Prance has since been circulated amongst aroma trade organisation members (Cropwatch also has a copy of this on file). By the time that Prance had left Cosmetics-Design Europe, Cropwatch was being pilloried on the IFRA website over its opposition to the QRA system (we think this has subsequently been taken down, after Cropwatch claimed that the piece had given us a lot of positive publicity, although there remains a brief mention in IFRA Newsletter Jan 2007). Basenotes invited Burfield and Houri to put their different cases, Burfield bringing up a number of issues at http://www.basenotes.net/columnists/20070223cropwatchvsifra.html. In contrast Houri (not a scientist) chose to give a short propaganda piece about IFRA's policy, its connectivity, its power & importance, not answering any of the specific issues raised (see http://www.basenotes.net/columnists/20070223cropwatchvsifra.html). 

New Developments

In a curious out-of-character move, EFFA have suddenly presented the Schnuch opinions to DG-Enterprise, for labeling requirements for 10 allergens of the notorious ‘26 allergens’ to be reconsidered, on the grounds that in trials, these ingredients rarely present as allergens and in three cases, have not presented at all (Schnuch et al. 2007, Schnuch 2005). This is hardly new; Cropwatch have been imploring the EU Commissioners to look at the Schnuch findings from July 2004 (pub. 2005) for 4 years. These misclassified ingredients are identified (Schnuch et al. 2007) as benzyl alcohol, benzyl benzoate, methyl heptine carbonate, hexyl cinnamal, anisyl alcohol, linalol, benzyl salicylate, amyl cinnamal, limonene & a-methyl ionone (see http://www.cropwatch.org/Cropwatch Claims Victory Over 26 Allergens.pdf). Let’s further consider the implications of this strange move by EFFA. Does it mean that EFFA are (at last) at variance with IFRA policy over the 26 alleged allergen situation? Where does the Schnuch evidence leave the QRA approach? (wrecked!). Does this also mean that EFFA are now pressing DG-Enterprise to consider adverse end-user data present in the Schnuch evidence? - this outcome was, of course, previously ruled as inadmissible to Cropwatch by the Regulator in a Brussels meeting in 2007. Or do different rules now apply for EFFA safety evidence submissions, as opposed to Cropwatch submissions? 

The Oko-test results of Schunch et. al (2004) also identified citral and farnesol in the "rarely found as allergens" category, although in a previous paper Schnuch et al. (2004) had found that farnesol was an important allergen. Nevertheless, as mentioned above, EFFA had previously presented evidence to the SCCP that citral & farnesol should be considered allergens under the QRA system. So (considering the less ambiguous citral case) are EFFA supporting some parts of the Schnuch evidence, but not other parts? It’s all very confusing. EFFA have also taken up the several Cropwatch references from the work of Hostynek & Maibach which broadly suggests that the evidence used to classify anisyl alcohol, amylcinnamic aldehyde, linalol, geraniol, citronellol, alpha-methyl-iso-ionone & methyl heptine carbonate as allergens is not sufficiently scientifically robust on which to base legislation. Again this would seem to potentially undermine the position of the QRA, so we have no idea of EFFA’s motives. It also reflects on the undue haste with which the EU Cosmetics Commission is acting these days, pushing industry for results & policies when the science isn’t sufficiently developed & mature to oblige them. 

IFRA in its Information Letter 801 (02.08.2008), are to introduce yet another costly QRA U-turn for industry, under the forthcoming 43^rd IFRA Amendment. Having sold (as a benefit) the fact that under the QRA approach, higher use levels could be introduced for some materials than the current IFRA Standards allow, in the next breath they change their minds, as “increased exposure due to elevated use levels presents a theoretical possibility that certain pre-sensitised individuals might experience an allergic contact dermatitis where previously they had not.” This gets the 2008 Cropwatch Prize for a Statement of the Bleedin’ Obvious, but we are so pleased that IFRA have caught up their thinking with everyone else on this matter. Unfortunately the financial penalty for industry is the re-writing of formulae & the re-programming of computers to re-align to the downwards exposure limits for the 14 new Standards already introduced under the IFRA 42^nd Amendment. 

Conclusions

The general realisation that excessive regulation from IFRA/RIFM, EFFA & the EU is killing aroma industry prospects is leading to increasing technical support for Cropwatch from within the industry itself, & from aroma ingredient end-users. Blinding people with science or using high-tech. methodology such as the QRA for safety testing belies the fact that there are fundamental weaknesses in this safety strategy, and no amount of arrogance & posturing by safety officials can obliterate this. The fact that IFRA are unable to defend the use of key aroma ingredients on a risk/benefits basis, and that the EU Commissioners have allowed excessive precautionary principled policies to dominate their agenda, means that the time is right for a new independent safety authority to come along and sweep these people away. 

References 

Dean J.H., Twerdok L.E., Tice R.R., Sailstad D.M., Hattan D.G. & Stokes W.S. (2001) “OCCVAM evaluation of the murine local lymph node assay. II Conclusions & recommendations of an independent scientific peer review panel.” Regulatory Toxicology & Pharmacology 34(3), 258-273. 

Sanchez-Politta S., Campanelli A., Pashe-Koo F., Saurat J.H. & Piletta P. (2007) "Allergic contact dermatitis to phenylacetaldehyde: a forgotten allergen?" Contact Dermatitis 56(3),171-2. 

Schnuch A., Uter W., Geier J., Lessmann H. & Frosch PJ. (2004) "Contact allergy to farnesol in 2021 consecutively patch tested patients. Results of the IVDK." Contact Dermatitis. 50(3), 117-21. Schnuch A. (2005) 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. 

Storrs F.J. (2007) “Allergen of the year: fragrance.” Dermatitis 18(1), 3-7.   

Technorati Tags: qualitative risk assessment,QRA,fragrance ingredients,IFRA,citral,farnesol,phenylacetaldhyde,tea leaf absolute,Cropwatch,bullying,23 allergens,allergens,perfumery

Notes and News

• P&F has gleaned statistics from Datamonitor on the growth of  the Fair Trade market, stating that "ethical consumerism will increasingly come to the fore as people shop for products they feel akin to politically, ethically and aesthetically."  Aromatic extracts such as essential oils, CO2's and absolutes are not even on the radar screen with the  regulators such as Transfair  and flo-cert.  My report on Cote d'Ivoire cacao production revealed that determining abuses will not be an easy job. The P&F article predicts a 15.7% growth through 2012 for the countries covered, concluding that "transparency and trust will become increasingly important currency in the emerging  'green'  marketplace." 
• Insect repellent products made with  Nepeta cataria should carry a warning to caution people not to use when hiking in areas where Cougars, Lynx, Bobcats or other large cats are present.  All cats (even those big guys) are attracted to catnip, and forest rangers have begun using it to attract Cougars for tagging and research.  All cats will have a physiological reaction to the chemical compound nepetalactone in catnip which has been found to induce a psychosexual response in both male and female cats. One might say that catnip has an aphrodisiac effect, however some cats can be very possessive of their catnip, and some cats have been aggressive after use.  We highly recommend that product manufacturers alert their customers of this potential danger. 
• As reported by Jennifer Minigh, PhD, in ABC's (American Botanical Society) Herbclip, a recent double-blind, randomized and placebo-controlled trial published in BJOG (British Journal of Obstetrics and Gynecology 2008) shows that saffron Crocus sativus L. looks promising for treating PMS (premenstrual syndrome).   Using the dried stigma encapsulated, saffron was effective in treating mild to moderate depression via serotonergic mechanisms.  This is likely the first study of saffron's effects on PMS, with 50 women participating ages 24-50 and comparisons to other studies are therefore probably not possible. 
• An upcoming Sandalwood Conference to be held in Kununurra, WA  promises to  "Revolutionize the Global Indian Sandalwood Supply."  Rob blogged about this briefly when news of the crop development and establishment of a production plant in Kununurra came out in December.  This news is creating new excitement, as expressed by Georges Ferrando, from Albert Vieille, who says with a processing plant due to be built in Kununurra next year, the region will become a world leader within five years.  "India is number one in supplying sandalwood oil, but I think very, very quickly, Kununurra will become the supplier number one in the world".  The growers are expecting the first harvest in 2014.  The conference will  present comparisons of plantation-grown Santalum album to that grown in the wild, an overview of the international fragrance market, the uses of naturals in fragrance, setting standards for a reliable supply, as well as cover issues of indigenous participation and environmental responsibilities.  In addition to featured presentations, there will be round table discussions and plantation tours.

The kind of aromatherapy article we don't need

An article about aromatherapy and essential oils has been published on Mike Adams Natural News web site.  Entitled Raise Your Immunity Frequency With Essential Oils to Beat the Common Cold, the article appears to have been cobbled together from old Young Living web sites and brochures--a mixture of science and pseudoscience that could tarnish the reputation of the Natural News web site, which has risen quickly to an Alexa rank of under 50,000 since its inception in late January.

The electrical engineer in me (BSEE 1965) has struggled for years with the concept of frequency as applied to essential oils. I've read what Young Living web sites say (mostly derived from Gary Young's book Aromatherapy: The Essential Beginning), looked at Bruce Tainio's web site, and read a bunch of stuff about Royal Rife. Since most of these materials are written in general terms (using technical terms that may or may not be understood by the person quoting them), it's hard to figure out exactly what they mean. Tainio, on his web site, is obviously amused by what he sees as misuse of the concepts he developed

If you find information about the frequency meter or about Bruce's research that did not originate from us, or that is not included in this web site, it may or may not be entirely accurate. Please remember to take it with a grain of salt. We do!

At any rate, I am both amused and chagrined by the attempt to use the frequency theory to justify and explain essential oil use. Even if the theory is valid (there seems be a dearth of published research) the author doesn't do a very good job of proving her case.

From an introduction explaining about frequency, she cites some research showing that stress or negative attitudes increase the likelihood of getting a cold (probably true), detours into avoiding antibiotics because they don't control viruses (also true) and throws in a pastiche of facts about colds, and eventually arrives at a conclusion: Lo, essential oils have a high frequency and can be used to raise the body's frequency, thus making it healthy!

Citing in vitro studies done by Young Living staff that showed that essential oils have anti-bacterial and anti-viral properties, and French practices of internal use, she admits that "While this is an over-simplification of the serious medicinal aspects of aromatherapy, it is helpful, nevertheless, in demonstrating the effectiveness of therapeutic essential oils in the medical arena."

The article list several essential oils claimed to be effective against cold viruses, including oregano, thyme, fennel, juniper cinnamon, rosemary and clove. It isn't clear how the oils are to be taken, but internal use is implied by the wording. There are no safety warnings or even suggestions that the oils should be diluted or might be best dispensed by qualified practitioners. There is no direct link to Young Living as a supplier, but there is a link to the author's web site and from there a broken link to a YL site.

Certainly the world of aromatherapy would be better served by an article that is more in accord with confirmed scientific theories of aromatherapy and which provides precautions for use. I remember meeting a woman several years ago who had had a liver transplant because in her naive state she overdosed on herbs that destroyed her liver. The same thing can happen from high doses of conventional drugs or essential oils.

Technorati Tags: aromatherapy,essential oils

Cropwatch Update on Citrus Oils

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.   

Cropwatch Concludes... 

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

There are two attachments to this post:  Citrus Developments Intro 03.08 and FC's - distribution in aromatic plants. 

Technorati Tags: IFRA,furanocoumarin,citrus essential oils

Furanocoumarins in cosmetics – worrying developments

IFRA IL 799. 

UPDATED to correct abbreviation error.

IFRA have just released an Information Letter (IL 799) on 'Controlling furanocoumarins in citrus & other essential oils', together with a document on FC's in cosmetic products. Ordinary members of the public, and citrus oil end-users who are not members of the requisite professional trade associations, may find this IFRA Information Letter difficult to locate, but essentially the letter notes the following: 

1. That a previous IFRA Standard limits FC's (specifically bergapten) to 15ppm in consumer products for UV-exposed skin.  Cropwatch comments: As far as we can establish, few perfumery companies have ever abided by this IFRA Standard, and a considerable number of individual working perfumers who we have previously contacted remained completely uneducated about FC levels in the aromatic ingredients with which they construct perfume formulae.  Little information either has been publicly available from any citrus product supplier. A recent suggestion by the Cosmetics Regulator (in a communication to EFFA) that FC's in aromatic ingredients can be estimated by HPLC, shows how removed these officials are from any economic & practical reality, and how they continue to only be able to suggest high-technology fixes which economically discriminate against the economic resources of smaller companies. 
2. Entry 358 of Annex II of the Cosmetics Directive prohibits FC's in cosmetics except for any natural presence in essential oils. In sun-protection & bronzing products FC's are limited to 1 ppm. Cropwatch comments: Again there is little evidence that there is any awareness of the universal enactment of this legislation within the EU marketplace.   
3. The SCCNFP Opinion SCCNFP/0392/00 September 25th, 2001 called for a limit of 1ppm of total "furano-coumarins & furano-coumarin like substances" in finished cosmetic products, an imposition which was fifteen times more severe as the existing (& probably little-adhered to) IFRA Standard mentioned above. Cropwatch comments: The SCCP Opinion on Furanocoumarins in Cosmetic Products (SCCP/0942/05), ratified on the 13th Dec 2005 is more recent. As usual, the SCCNFP's/SCCP's spoon-fed comprehension of the ingredient toxicology in both instances was incomplete, and its "experts" did not fully appreciate that not all FC's & "furano-coumarin like substances" necessarily present a photo-carcinogenic risk; indeed some might show photo-protective properties. The Opinion was therefore contemptuously received, as well as being practically unworkable in the absence of clear data showing FC concentrations across the huge range of FC-containing aromatic ingredients in the perfumer’s palette. Not the least, the imposition of such a severe limit for FC's in finished cosmetic products would practically eliminate the use of citrus oils in fragrances, as Cropwatch has previously extensively discussed in its Newsletters over 2006-2007. 
4. According to IL 799, "the industry" (individual company identities withheld), the industry-funded RIFM organisation and the EU Commission have reportedly embarked on a collaboration which has resulted in a Risk Assessment which "was shared with the European Commission at the end of 2007" (public accessibility of this Risk Assessment is unstated). Reportedly, this proposes that for leave-on products, a limit of up to 5 ppm FC's from a combination of any of the 6 following FC markers will be allowed: bergapten, bergamottin, byacanangelicol, epoxy-bergamottin, isopimpinellin & oxypeucedanin. A less restrictive limit of 50 ppm of FC's  for rinse-off products is also proposed. IFRA have suggested that "the Industry", for whom it increasingly seems to be the self-appointed spokesperson, meets DG-Enterprise/DG-Sanco "to explain & discuss its proposals in more detail". Cropwatch comments. The specter of a few un-named megacorporations which are potentially able to finance safety research and thus to dictate areas of EU safety policy is alarming, especially as complex bureaucracy such as that in the above scheme, will advantage the larger aroma concerns, and discriminate against the smaller companies - a worrisome area which could so easily become considered as falling into a restrictive practice.

CONCLUSIONS 

Cropwatch maintains that, as we said before, the case against the photo-toxicity of individual FC’s, as presented in previous SCCP Opinions such as SCCP 09542/05, remains scientifically non-robust, and there is a lack of supporting knowledge, understanding & experimental & technical data. For FC’s occurring in natural aromatic products, matrix effects & the anti-carcinogenic potential of other co-occurring substances remain unclear. Whether any newly presented evidence will instantly clarify this position is uncertain, because although we are supposed to live in a European democracy and there is supposed to transparency in all EU Commission safety policy dealings, key documents relating to safety studies in this area continue to be withheld from the general European public.   

Cropwatch suggests the following to its supporters: 

1. The proposed legislatory conspiracy between unidentified industry concerns, IFRA-RIFM and the EU Commission, to limit FC levels in finished cosmetics for sale in the EU marketplace, is vetoed by the cosmetics & natural products trade in general. This is because the EU Cosmetics regulatory officials have so far failed to clearly & unequivocally establish a robust case of need to control the existing levels of consumer exposure to FC's in cosmetics. 
2. That the lack of transparency in the evidence-submission process surrounding alleged FC toxicity/carcinogenicity data is corrected by EU officials & advisors. This sort of secrecy is not acceptable in a supposedly democratic European society.

It should also be noted that the outfall from the suggested Risk Assessment allegedly submitted by IFRA/RIFM to the EU Commission for its consideration in late 2007, is likely to do little to address the problems of the continued freedom to use certain citrus ingredients in perfumery/natural perfumery. We all know in our heart-of-hearts that the more the larger Aroma Corporations fund the activities of regulatory-centered bodies such as RIFM, IFRA, EFFA etc., the quicker the end will come for unrestricted natural ingredient usage in perfumery.    

Tony Burfield
Cropwatch.

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Enviroblog: New York Times seduced by fragrance industry

Enviroblog takes on the New York Times for an article on the fragrance industry and the practice of developing patented fragrance ingredients.  Chandler Burr in The Times compares the fragrance industry to the pharmaceutical industry development of proprietary  drugs such as Lipitor. Enviroblog points out that there are differences, since the FDA regulates the drugs for safety, but the fragrance ingredients are not regulated and the safety/health effects are often unknown. Burr argues in favor of the synthetic fragrances,pointing out that they may cost less and may be used in place of natural ingredients such as rosy ketones that set off allergic reactions at high doses.

Enviroblog argues that the claims of ecological soundness in the Times article are invalid because the perfume and body care ingredients end up polluting the overall ecosystem, citing research that phthalates from fragrance products can affect the reproductive hormone levels of fish. The Times has [mostly] ignored any environmental or safety issues entirely in their article.

For those of us in the natural products industry, the entire argument almost seems outside our purview. Our argument is that natural products are better and safer, and the public seems to be increasingly agreeing with us, or at least the mainstream large corporate cosmetics and fragrance industry perceives that is the way it is, as they are starting to offer more organic and natural products, even as they continue to develop more synthetics. The reality is that we increasingly are living in a world where money and property ownership are taking over. The impact of this in the fragrance industry isn't as great as in, for example, the case of GM Crops or patenting of strains or seeds, because unless we want to get really rich, we have the option of ignoring them and doing our own thing. Even the environmental impact of the bad things in fragrance ingredients is (probably) miniscule compared to the problems of plastic pollution, feedlot pollution, or the causes of global warming. But it all adds up.

The key here is full disclosure of the ingredients and effects, sensible regulation of hazardous or toxic ingredients, and education of consumers, manufacturers, and suppliers about the issues involved. The mainstream media, such as the NY Times, will probably side with the corporate owners of intellectual property, and the blogs, the small indie manufacturers and the natural products users will probably side with the Earth.

I guess I've turned this into a populist issue.  Any comments?

Cropwatch Claims Victory Regarding “26 Allergens” Legislation

Feb 2008

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 Directiv