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

Cropwatch Five Years on

Part 1. Threatened Natural Aromatic Species

Cropwatch came into being around 2003-2004 in order to directly address concerns about the over-exploitation of natural aromatic ingredients, and their over-regulation by officials prone to the excessive influences of lobbyists from the pharmaceutical & chemical industries, from toxicologists & dermatologists, and, as we have learned to our considerable dismay, from various environmental groups. At present Cropwatch remains independent & non-financed, but with a level of popular support which we believe is (conservatively) over twenty times that of any industry-financed organisation. In order to summarise progress over the past 5 years or so of Cropwatch’s activities, we have divided the reporting into two parts: this part reporting on threatened natural aromatic species, and the second (in preparation) looking at the non-transparent world surrounding the over-regulation of our natural aromatic materials.

Threatened species

Since the essential oils industry/aroma trade has generally been either too shy to come clean about its use of commodities from threatened species, or is actually in denial about it, Cropwatch decided to write an article on the subject for the Endangered Species Update magazine in 2003 (see http://www.cropwatch.org/unethical.htm). This was well-received at the time, and article reviews were featured in leading trade magazines such as Soap, Perfumery & Cosmetics. Further work challenging individual companies who sell or use commodities from rare or threatened species has been on-going since 2003, with some limited measure of success, but when challenged these companies invariably fake surprise, become hostile or defensive, or plead ignorance.

Our major work in this area is the “Update on threatened aromatic plants used in the aroma & cosmetic industries” now in its corrected, expanded and updated 5th revision (93pp), and Cropwatch has the IUCN’s express permission to quote the Red List Status of the individual aromatic species identified. This 5^th version includes an extended section on natural product status, & a revision of the alphabetical data-base of threatened species, including rosewood oil (see below for URL). Most of the points we need to make at this juncture are contained within this document. In the introductory lead-in, we quote Bobbi Low (2004) from the periodical Threatened Species: “Many problems in managing and protecting endangered species arise not from our ignorance of the species’ ecology, but from human conflicts of interest”.

Nevertheless, to counter any claims of ignorance, and also attempting to cover “human conflicts of interest”, Cropwatch decided to make collected information about threatened species available on its website in the wider public interest. To this end we have constructed an on-going series of periodically updated articles and data-bases, which either provide information on the subject, or point to where it can be found. Topics cover so far can be listed out as follows:

Extensive bibliography on agarwood (1st revision 2008: 35pp): http://www.cropwatch.org/agarbib2008.pdf

Agarwood files – chemistry, botany, microbiology etc. (2004) at: http://www.cropwatch.org/agarwood.htm

Extensive sandalwood bibliography (4^th revision 2008: 67pp): http://www.cropwatch.org/santalum.pdf

Ambergris article (2005) at: http://www.cropwatch.org/ambergris.htm and (2006): http://www.cropwatch.org/ambergrisupdate.htm

A short note on the ecological status of Cedarwood Atlas (2004): http://www.cropwatch.org/cedarwood.htm

Update on threatened aromatic plants used in the aroma & cosmetic industries (5^th revision 2008: 93pp): http://www.cropwatch.org/v105.pdf

Exploited trees: some brief sketches (2006): http://www.cropwatch.org/cropwatch13.htm

Chinese medicine consumes threatened species (2005): http://www.cropwatch.org/tigers.htm

Rosewood sustainability (2004): http://www.cropwatch.org/cropwatch6.htm

Australian sandalwood oil: a tale of spin & hype? (2004): http://www.cropwatch.org/cropwatch2.htm

Documents in preparation include ‘Rosewood oil – the real story’ and ‘Misguided attacks on alternative medicine’ which is intended to include the still unfolding gynecomastia - lavender oil - tea tree oil situation. We are also in the process of preparing a ‘Threatened species in the natural drug trade’ data-base, although this will be a long task. We are always grateful for contributions, corrections or suggestions for any of these items, most of which are-, or intended as-, continuously upgraded living documents.

Sections on sandalwood & agarwood in the “Update on threatened aromatic plants….” particularly, go hand-in-hand with the extensive sandalwood & agarwood bibliographies listed above. You should be able to make your own minds up from some of this data about the claimed sustainability of commodities from certain species, and to learn the identities of some of the companies who are using these commodities.

Adulteration

Another topic that the aroma industry really doesn’t want to talk about is the widespread practice of the adulteration of essential oils and aromatic materials. Cropwatch presented (a subsequently much-plagiarised) account of this practice slightly updated at http://www.cropwatch.org/adulterationupdate08.pdf. Whenever natural aromatic commodities go short – as lemon oil is at present, due to widespread global crop failures – the natural ingredient buyer can particularly expect an increased risk of buying substandard, adulterated or blended material. The failure of the IFRA-RIFM-REXPAN hierarchy to have ever investigated the health & safety aspects of adulterated fragrance ingredients is shameful, and clearly illustrates the limitations & no-go areas for trade-funded, non-independent safety organisations. Unfortunately, the hapless regulators of the profession are almost totally dependent on organisations such as these for direction & technical information. But you would all know that already…….

Tony Burfield

Co-founder Cropwatch

Technorati Tags: threatened aromatic species,Essential Oil Adulteration

The Natural discussion continues

The Society of Cosmetic Chemists has weighed in on the question of "natural" at its annual scientific seminar last month in Orlando, according to a recent Happi article entitled "It's Not Natural..." The article discusses both natural and organic definitions, most of which we have mentioned here in previous posts.

Speakers at the conference pointed out that there are six major organizations trying to define natural, which is not exactly true; five them are working on organic standards and only one (NPA) has even dealt with the term "natural" in their standard. The NIRC and the IANPP weren't even mentioned, but they aren't major organizations so I supposed they don't count.

Issues other than standards, but related to natural/organic manufacturing including green chemistry and sustainable packaging.  There was a review of regulatory issues, pointing out that there is no general consensus on the meaning of "natural" and that because the FDA has no definition, it may be up to the Feceral Trade Commission (FTC) might resolve the issue based on whether claims made are "clear and definitive".

What is clear at present is that the whole discussion of natural is not definitive, as pointed out at the seminar, and as pointed out on this blog.

Technorati Tags: natural,natural definition,organic,organic personal care products

FDA enters debate on Natural

We've blogged before on the meaning of "natural" when applied to skin and body products, discussing in particular the definitions put forth by the Natural Products Association (NPA) and the Natural Ingredients Resource Center (NIRC).  Now the FDA (Food and Drug Administration) has reversed itself in a ruling on high fructose corn syrup (HFCS) and ruled that it can be considered "natural" under certain manufacturing processes, according to an article in FoodNavigator-USA, a food industry publication. The ruling came in a letter from the FDA to the Corn Refiner's Association (CRA).

It appears that the ruling is based on technicality having to do with the production process for HFCS. Even though the process uses a synthetic fixing agent, it supposedly doesn't come into contact with the HFCS, so that it is acceptable as "natural".  As the article points out, however, the Sugar industry as well as other consumer groups argue that HFCS isn't natural because

its chemical bonds are broken and rearranged in the manufacturing process.

What this really points out is that there isn't yet a good standard definition for what is "Natural".  According to the FDA letter, it makes decisions on a case-by-case basis.

A search of the FDA website reveals this interesting statement:

The term "natural" has not been defined in FDA's law (the Federal Food, Drug, and Cosmetic Act) or in FDA's regulations.

A review of the Google Results for "FDA natural" reveals a number of recent "natural" issues with the FDA, including in addition to HFCS the issues of Stevia, various "natural" cures for cancer and other diseases, some paranoia about health freedom, and the discussion of whether they will define "natural." This blog post from April 2008 is a good discussion of some of the issues, although it is now outdated by the new FDA ruling.

According to SourceWatch, a website that tracks "the names behind the news" the CRA has spent $20-30 million on a public relations and advertising campaign in support of HFCS.

The FDA now seems to have thrown in its lot with the CRA.  I'm sure we haven't heard the last of it.

Technorati Tags: HFCS,high fructose corn syrup,natural standards

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

Natural Beauty Summit tackles certification fragmentation

Cosmetics Design-Europe reported on the natural Beauty Summit held last month in New York with the headline Natural Beauty Summit tackles certification fragmentation.  We reported in this blog on the Summit before it happened, and although we were unable to attend, have been gathering information that goes beyond the sketchy report in CD-E, and we'll be reporting more in depth about the various standards and the process of their development in the near future.

Apparently the discussion got rather heated as the panel made presentations focusing on six different approaches to standardization for certification of natural and organic personal care products in North America: the USDA NOP, a Retailer's standard proposed by Whole Foods markets, Organic standards proposed by NSF and OASIS. CD-E referred to the NSF standard as being for consumer goods, but it appears to us to be equivalent to the OASIS standard and they seem to be two wheels on the same unicycle.

However, when it came to the panel discussion, Horst Rechelbacher, founder of Weleda and Intelligent Nutrients, and chair for the conference's first session on Sustainability, chose to challenge the panel on the fact that they were contributing to the fragmentation of the certification process and consumer confusion.

The panel discussion became heated, with Rechelbacher accusing the panel representatives of being self-serving and panel members defending themselves by explaining that the development of the market in the US had made private certification necessary.

Rechelbacher apologized for his comments, but stressed that he wanted to see greater regulatory harmonization.

The Natural Products standard proposed by the NPA apparently wasn't included in the discussion. As we pointed out in our discussion of that standard (see link) the orderly Standards development process mandated by ANSI isn't being followed by most of the standards developers. The one exception is the standard being proposed by NSF, which is going through the ANSI standards development process and has gone through it's first round of review, although the public has apparently not been brought in on the process yet. And neither have the independent small producers.

Coming soon: a comparison of the NSF and OASIS organic standards.

Technorati Tags: OASIS Standard,Body Care Standard,Organic Standards,Natural Product 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.     

Book Review: Medicinal and Aromatic Crops

Medicinal and Aromatic Crops: Harvesting, Drying and Processing Edited by Serdar Oztekin and Milan Martinov. Haworth Press: New York. 2007. ISBN 978-1-56022-975-9.

This book was published in 2007, but we recently obtained a copy for our library and realized that it should be in the library, or on the work desk, of anyone who is involved in the production or processing of medicinal or aromatic plants (acronymized in the book as MAP), or even those who have a curiosity about where essential oils come from or how they are or can be produced.

The book starts out with an excellent introduction to the issues involved in aromatic plant production and sustainability as the agricultural system changes from the previous norm of wildcrafted MAP to the more complicated processes of cultivation and the problems of assuring quality, purity, and safety with the transition from Good Wildcrafting Practices (GWP) to Good Agricultural Practices (GAP) which are often unknown to the farmers. There is a good discussion of related environmental issues. One shortfall is that there is no discussion of organic production.

The focus of the book is on mechanization, which the editors claim is generally neglected in the literature and in practice for a variety of reasons, but which should be considered not only to improve production quality  but to improve working conditions for workers. Manual and semi-mechanized methods are not neglected, and renewable energy sources are discussed.

The chapter on Extraction gives a good overview of all the processes commonly used for aromatic plants. The discussion of distillation is illustrated by a thorough description of the production of Turkish rose oil.

A chapter on Industrial Utilization of MAP unfortunately relegates Cosmetics, Perfumery, and Aromatherapy to four paragraphs, with Aromatherapy in a single (short) paragraph, hardly doing justice to the usage.

The book closes with a chapter covering the management of MAP agricultural enterprises and an Appendix discussing a software program that has been developed to assist farmers in the decision making process.

The book is well illustrated with photos and drawings, unfortunately in black and white, and is extensively referenced and well indexed.

Technorati Tags: Medicinal Crops,Aromatic Crops,Medicinal and Aromatic Crops

Organic/Natural Standards to be Discussed at Upcoming Meeting

The big players in the Beauty Products World are gathering together in New York later this week at "The Natural Beauty Summit" to "create a forum to learn and discuss the key challenges the cosmetics industry faces in the areas of natural and organic products as well as sustainability" . . . or so says the program for the conference, to be held at the Hilton Hotel in New York City May 15-17. This is a followon to a similar summit in Paris last November, to be followed by a sequel, again in Paris, in October 2008.

Sponsored by Organic Monitor and Beyond Beauty Paris, the main focus of this conference will be Natural Cosmetics with a major session on Standard & Regulatory Issues followed by a panel discussion, and the next day a Natural Cosmetics Workshop focusing on "an assessment of the growing number of standards and certifications for natural and organic cosmetics . . . [with] a critical review of the major standards, comparing and contrasting the similarities and differences between them."

The list of standards and proposed standards that will be covered at the session is:

• A Retail products standard proposed by Whole Foods
• the USDA National Organic Program Standard applied to Cosmetics
• the American NSF Standard
• the OASIS Standard
• A review of European natural and organic standards harmonization
• ECOCERT and BDIH

The aromaconnection blog will be following these issues closely as they develop.  Notably missing from the above list is the NPA (Natural Products Association) standard we blogged about yesterday and last month. We are working on a table showing details of the standards and comparing their features.  In fact, we are probably duplicating what may show up in the proceedings of the NBS (if there are any), but we hope to get it into print sooner.

Organic Monitor, one of the co-sponsors of the NBS, predicts that 2008 will be the beginning of "an industry shake-up" as various standards are unveiled in Europe and North America. In this linked article, they reference several standards that are not included on the list above. They also express concern about fragmentation that could lead to a reduction of trade, but express also the "more optimistic view" that Cosmetics might follow the lead of the textile industry and develop a harmonized global standard.

In the meantime the infighting has already begun. OCA and Dr. Bronner's have challenged what they call "weak" ECOCERT and OASIS standards, according to this OCA Press Release widely reported in the media mid-March. And as we reported yesterday, the C.A.M. Report is somewhat skeptical of the whole idea.

We can probably look forward to an exciting year!

Technorati Tags: organic standards,natural standards,cosmetic standards,NSF,OASIS Standard,ECOCERT Standard,BDIH Standard

Natural Products Association Rushes ahead with a "Natural" Product Standard

Without allowing much time for industry review and feedback, the Natural Products Association has moved to implement their "Standard and Certification for Personal Care Products." As discussed previously on this blog, a meeting was held to discuss this standard in early April, and based on our research online we suggested that more work was needed to integrate standards.  The NPA has moved ahead and published what they describe as an "initial standard" on their website, and is setting up a seal of approval and a process for certification. The standard is intended to encompass "all cosmetic personal care products regulated and defined by FDA."

In my opinion, this is a preemptive move on the part of the NPA to seize the initiative in establishing a standard, without following the usual process for standards development. The international Standards Association (ISO), which is the authoritative international standards body, develops industry wide, voluntary standards based on a consensus of all interested parties. They suggest three main phases in the standards development process:

1. The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. The latter proposes the new work item to ISO as a whole. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. This phase is usually carried out in working groups which comprise technical experts from countries interested in the subject matter. 
2. Once agreement has been reached on which technical aspects are to be covered in the standard, a second phase is entered during which countries negotiate the detailed specifications within the standard. This is the consensus-building phase. 
3. The final phase comprises the formal approval of the resulting draft International Standard (the acceptance criteria stipulate approval by two-thirds of the ISO members that have participated actively in the standards development process, and approval by 75% of all members that vote), following which the agreed text is published as an ISO International Standard.

Of course here we are not yet proposing an International Standard. The NPA is an industry sector, that has recognized a need for a standard. But that is where the process has broken down. There has been no public consensus building process, I haven't seen the establishment of a working group of technical experts, and even though the ISO suggests the publication of interim standards (which is what they are calling the current attempt).

The C.A.M. report takes a very skeptical attitude towards the NPA seal, essentially accusing the NPA of producing a marketing gimmick.  He appears to have gotten his information from the press release and not the detailed standard, but who am I to argue with him?  He's probably right.

Technorati Tags: Natural Products,natural products standard,NPA,natural Products Association

Perfume Politics: The Oppressive Perfumer's Guild

Guilds are perhaps the precursors of modern trade unions, and also, paradoxically, of some aspects of the modern corporation.  Guilds are actually small business associations and have little in common with trade unions.  They are more like cartels in that they assume exclusive privilege to produce certain goods or services or dictate standards of a profession.  Guilds can establish restrictive guidelines or a rigid system and can exclude those who do not abide.  Guilds emerged with a similar spirit and character to the original patent systems and are not generally conducive to a democratic free flow of development and interaction.   

In the modern democracy, we have created nonprofit organizations or NGO's intended to benefit a group by collective efforts and by providing public education or  services that benefit society.  Legal nonprofit corporations receive tax relief, but are required to provide public reporting and transparency.  Such nonprofit endeavors are usually governed democratically and operated by officials periodically elected from within the membership.  This creates a structure that will evolve the endeavor into the future separate from and not dependent on or owned by any one member. 

The French Perfumer's Guild of antiquity was perhaps the worst example of the power a Guild over its members.  Established by an edict of King Philippe-Auguste in 1190 (reconfirmed by patent letters by King Jean in 1357, again by King Henri III in 1582, and again by Louis XIV in 1658, the "confrerie des Maitres Gantiers et Parfumeurs") that primarily gave glovemakers of the extended medieval period the exclusive right (i.e., monopoly) to manufacture and sell cosmetics of all types.  Why glovemakers, you ask?  Gloves were made from leather tanned using urine and other toxic and putrid substances and needed to be scented before they could be respectably worn.  The glovemakers were wealthy manufacturing businesses and they were quite adept at organized efforts to lobby each respective monarchy, reminding of the importance of their role in medieval society and thereby acquiring the sanction necessary to maintain their monopoly.  And, one can also suspect that favors were extended.  Today, we might call them bribes.  As you can see, this monopoly continued for a long time and was grounded in the necessity for perfuming what would otherwise be unusable products - leather gloves.   The corporation or guild, headed up primarily by master glovemakers,  established the sole credentials of those who could sell gloves as well as perfumed goods and dictated the kinds of products they could manufacture . . . a long list including sachets with perfumed powders, compositions used in burners for environmental scent, pomades for the hair, soap, cosmetic creams, scented gloves and even tobacco.  A quaint novelty to us today, but in common use then, was the "oyselets de Chypre."  These were cloth birds in bright colors, decorated with feathers and stuffed with aromatic powders, then placed in ornate cages and hung from ceilings or walls to add fragrance to a room.

By 1750, there were 250 master perfumers, members of the corporation who had served 4 years as an apprentice and an additional 3 years as "compagnons" before reaching the status of master.  For all intents and purposes, they were slaves, not free (until the Revolution that is) to work outside the confines of the guild or to develop their own trade and commerce.  Only rarely were there exceptions, a notable one being René Le Florentin, Catherine de Medicis's personal and favorite perfumer.  Le Florentin had a reputation for talent in creating scents and fabricating poisons!  And, obviously Catherine was well positioned to demand for him premature status.

Everything changes.  Along  came the French Revolution, rendering perfume and other objects considered frivolous luxury symbols of excesses of the aristocracy out of favor.  With the exception of popular scents like, "parfum á la Guillotine".  Under the Terror, choice of scent indicated political affiliation, a kind of odorous password.  Politically correct scents could literally save one from execution.  Napoleon's return from conquering (so he claimed) Egypt, along with his renowned heroic status gave him the power to re-establish the importance of French manufacturing to the glory of the nation.  His fondness for cologne bode well for the lagging perfume industry, establishing imperial commissions as well as scientific and technological research in organic chemistry . . . a science that would revolutionize the perfume industry in the latter half of the 1700's.   Thus, the adjective "French" is aligned with the noun "civilization" and under a new empire, cosmetic luxury products had a more general and populist allure.

One would hope that we are beyond the oppressive restrictions imposed on the medieval creative perfume artists of the day and that individuality and inventiveness are the modern dictates for his or her endeavors and acceptance.  And, that perfume guilds are fashioned after the democratic principles of modern non-profits and NGO's. 

References

Stamelman, Richard, "Perfume: A Cultural History of Fragrance from 1750 to the Present", 2006, Rizzoli International Publications, Inc.

Classen, Constance, Howes, David, Synnott, Anthony, "Aroma: The Cultural History of Smell", 1994, Routledge Press

Newman, Cathy, "Perfume: The Art and Science of Scent",  1998 National Geographic Press

http://www.wikipedia.org/

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.   

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Earth Day 2008

"The President in Washington sends word that he wishes to buy our land. But how can you buy and sell the sky? The land? The idea is strange to us. If we do not own the freshness of the air and the sparkle of the water, how can you buy them? Every part of this earth is sacred to my people. Every shining pine needle, every sandy shore, every mist in the dark woods, every meadow, every humming insect. All are holy in the memory and experience of my people. We know the sap which courses through the trees as we know the blood that courses through our veins. We are part of the earth and it is part of us. The perfumed flowers are our sisters. The bear, the deer, the great eagle, these are our brothers. the rocky crests, the juices in the meadow, the body heat of the pony, and man, all belong to the same family. The shining water that moves in the streams and rivers is not just water, but the blood of our ancestors. If we sell you our land, you must remember that it is s