the aromaconnection blog

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.   

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

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 sacred. Each ghostly reflection in the clear waters of the lakes tells of events and memories in the life of my people. The waters murmur is the voice of my fathers' father. The rivers are our brothers. They quench our thirst. They carry our canoes and feed our children. So you must give to the rivers the kindness you would give any brother. If we sell you our land, remember that the air is precious to us, that the air shares its spirit with all the life it supports. The wind that gave our grandfather his first breath also receives his last sigh. The wind also gives our children the spirit of life. So, if we sell you our land, you must keep it apart and sacred, as a place where man can go to taste the wind that is sweetened by the meadow flowers. Will you teach your children what we have taught our children? That the earth is our mother? What befalls the earth befalls all the sons of the earth. This we know: the earth does not belong to man, man belongs to the earth. All things are connected like the blood that unites us all. Man did not weave the web of life, his is merely a strand in it. Whatever he does to the web he does to himself. One thing we know: our god is also your god. The earth is precious to him and to harm the earth is to heap contempt on its creator. Your destiny is a mystery to us. What will happen when the buffalo are all slaughtered? The wild horses tamed? What will happen when the secret corners of the forest are heavy with the scent of many men and the view of the ripe hills is blotted by talking wires? Where will the thicket be? Gone? Where will the Eagle be? Gone! And what is it to say goodbye to the swift pony and the hunt? The end of living and the beginning of survival. When the last red man has vanished with his wilderness and his memory is only the shadow of a cloud moving across the prairie, will these shores and forests still be here? Will there be any of the spirit of my people left? We love this earth as a newborn loves its mothers heartbeat. So, if we sell you our land, love it as we have loved it. Care for it as we have cared for it. Hold in your mind the memory of the land as it is when you receive it. Preserve the land for all children and love it, as God loves us all. As we are part of the land, you too are part of the land. This earth is precious to us. It is also precious to you. One thing we know: there is only one God. No man, be he red man or white man, can be apart. We ARE all brothers after all."

      -Chief Seattle

The nature Conservancy Earth Day Ideas
Take action for climate crisis solutions at we
Recycle old computers, cell phones and other electronics
Earth Day official events and activities
Professional advice for business sustainability initiative
Earth Day Facts from Rochester, NY plus more links
Make every day Earth Day from Madison, Wisconsin
Adverse effects of palm oil by Dove from Greenpeace
We can do it! from Sierra Club
The Rainforest Initiative
Whitefeather Forest Initiative
The African Conservation Foundaton
Long list of intragovernmental, governmental and private (NGO) environmental orgs

That ought to keep us busy.

Happy Earth Day! from all of us at the aromaconnection group blog.  

aromatisches Blog - Aromatics Blog

Das aromatische Blog widmet sich den Düften und Wohlgerüchen – dem Parfüm. (The aromatic blog devoted to the scents and smells good - the perfume.)

I've added a new blog to our perfumery blogroll: aromatisches Blog. It's in German, but can be easily translated with Google or other translation software, although the translations are a bit awkward.

Recent posts have discussed Benzyl Acetate (a constituent of jasmine); the difference between Perfume and Cologne; The history of perfume in Greece and mythology; working with crystalline materials; aromatic patchouli; the Berlin Botanical Garden (with plant photos); ESTEBAN patchouli perfume; the history of perfume in the Bible; and some great paintings from 1922 demonstrating that Perfume alone . . . is often not enough . . . you need to have some water.

The blog has been active since July 2007. Note that this blog is not strictly natural perfumery.

New Book "examines" Alternative Medicine

A new book due to published in England later his month (Trick or Treatment? Alternative Medicine on Trial by Simon Singh and Edzard Ernse, published by Bantam on April 21 at £16.99) is excerpted in the [London] Daily Mail with the title Are we being hoodwinked by alternative medicine? Two leading scientists examine the evidence.

Illustrated with a provocative photo showing oil being poured from a vessel containing a rose onto the back of a nude woman (suggesting Rainbow Therapy? or aromatic massage? or?) the authors claim to be evaluating the claims of alternative medicine "by using the principles of evidence-based medicine."

The article includes information on Alexander Technique, Aromatherapy, Bach Flower Remedies, Chiropractic Therapy, Hypnotherapy, Magnet Therapy, and Osteopathy and includes a sidebar on "Best and Worst Herbal Remedies."

It's hard to evaluate the information presented in the excerpt from the book prepublished in a newspaper, since there are no references given and the information presented is sketchy at best.  For example, the section on aromatherapy is:

• AROMATHERAPY

WHAT IS IT? Plant essences (known as "essential oils") are used to treat or prevent illnesses or enhance wellbeing. There are several ways of doing this. Most commonly, the diluted oil is applied to the skin via a gentle massage, but it can also be added to a bath or diffused in the air.

Aromatherapists believe that different essential oils have different specific effects. Aromatherapy is advocated for chronic conditions such as anxiety, tension headache and musculoskeletal pain.

DOES IT WORK? Some clinical trials confirm the relaxing effects of aromatherapy massage. However, this is usually short-lived and therefore of debatable therapeutic value. Some essential oils do seem to have specific effects. For instance, tea tree has anti-microbial properties. However, these efects [sic] are far less reliable those of conventional antibiotics. There is no evidence that aromatherapy can treat specific diseases.

I've had personal experience with several of the therapies covered in this article, and I'm sure that they work. In the case of Aromatherapy, Herbalism, and Magnet Therapy, I'm familiar with enough evidence to suggest that, when used appropriately, they do work.  I've experienced Chiropractic therapy, Massage, and Osteopathy and I can report varying success. I've also experienced our conventional allopathic medicine system with varying success. My personal opinion, as a user of these systems, is that an educated integrative approach is best. In theory, the sort of information included in this book is what is needed for the consumer to evaluate therapies so that they work with their medical providers to get the best possible care. Based on the summary of Aromatherapy above, it would appear to be nothing of the kind. I guess we'll have to wait for the book.

This book appears to be part of a well orchestrated campaign in the UK to discredit alternative medicine.  The same campaign is going on, to a slightly lesser degree, in the US. We've seen that in the media recently, as previously discussed in this blog.

 

Technorati Tags: aromatherapy regulation,alternative medicine,CAM

Aromatherapy Thymes Notable Launch

MrMagazine.com, a website/blog for the magazine industry, has declared Aromatherapy Thymes magazine as one of the "30 Most Notable Launches of 2007."

There are many health and medicine magazines jockeying for a position on today’s newsstands, but few give readers the type of information that Aroma Therapy provides which is why it has made it on the list of top launches for 2007.

Mr. Magazine has interviewed Patricia Carol Brooks, the Editorial Director, about the process of creating the magazine. She found her two biggest challenges to be "maintaining the integrity of the essential oil trade through informative articles and staying in contact with essential oil distillers in the U.S and abroad and coordinating the distribution channels for our market." By 2011 she expects the magazine to be "recognized worldwide as a reliable reference for aromatherapy and a publication that brought the distilling, trade, sell and distribution of essential oils to forefront."

There were a total of 715 new magazines launched in 2007, so this actually a fairly significant honor.

The blog link for the interviews is here. (The link above is to their web page, which is slightly abridged.)