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

Saturday Night Lavender Blogging

I found this while Googling bees and lavender to respond to a comment recently added to an old post from dave, who inquired about why bees become docile while on his lavender. He notes that some have died.

Has anyone else observed this phenomenon?

While I was Googling also found this link to Sleepy Bee Lavender Farm in Connecticut. Check out their link page for some good links for lavender growers.

Technorati Tags: lavender,bees,colony Collapse Disorder,sleepy bees

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

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

Notes and News

• Organic Monitor reports that there is an increase in the acreage of organic citrus groves in Florida. They focus on juice, but this should lead to better availability of organic citrus oils. 
• The C.A.M. Report has resurrected the Lavender/Tea Tree Gynecomastia issue again, by reposting an old post from 2007 without updating it to include information about challenges to the original research. 
• In the same post the C.A.M. report mentioned (without citation) a report that in 2005 essential oils were linked to 7,282 reports to poison control centers. UPDATE: JR forwarded the citation in a comment. He reported on this in the C.A.M. Report here. The article cited was here. The original source (PDF) of the data was the 2005 report of the American Association of Poison Control Centers.
• A new blog on food and local agriculture has been added to our Agriculture Horticulture link roll: La Vida Locavore.  Worth checking out if you like food.

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

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