CROPWATCH NEWSLETTER

  

Vol 2   Issue 1    No 2

 

April 2006 - re-issue

 

      

 

 

www.cropwatch.org

Editorial

The lunacy surrounding legislation based on over-deployment of the precautionary principle apparently knows no bounds. This week we learn that, under new rules, the UK HSE are banning passengers from taking tins of paint on buses, because of… err, wait for it… hazards to fellow passengers from the fumes (paint is apparently a hazardous article - you can only carry it onto a bus in a bag!). We have yet to hear evidence of a catastrophic failure of containment, such as, say, a large paint spill of wheatstraw easy-on water-based emulsion consequently snuffing out shoppers, or causing serious injury on the top deck of a number 19 bus. But apparently, just in case, a 73 year old person carrying a paint tin was recently ejected from a number 9 bus in Cardiff – well, he had no bag you see! And he wasn’t well, and it was raining….but anyway, if the stuff is so dangerous when it escapes from the tin, how come we are allowed to take it home unsupervised and without being issued with full personal protection (body suits, gloves, goggles, breathing gear etc.). Is there something that they aren’t telling us?

 

In other areas, normally it would be ourselves who are trying to conjure up interest from our supporters, in subjects that we believe are important to natural botanical product users. Presently, people are coming to us – over the issue immediately following…

 

SCCP Opinion on Furanocoumarins in Cosmetic Products (SCCP/0942/05), ratified on the 13th Dec 2005.

In a nutshell, many of you out there apparently believe that the imposition of a 1 ppm limit of furanocoumarins (FCF’s) in cosmetics, as proposed in this SCCP Opinion, would basically be the death knell for Natural Perfumery (and cause complete havoc in Conventional Perfumery). There is already an IFRA limit of 15 ppm for bergapten (5-MOP) in fragrances not washed off the skin exposed to sunshine – but it is Cropwatch’s opinion that this area is very little understood by perfumers, and the concentration limits are generally not observed by perfumery companies. This is partly due to a lack of information on FCF’s in ingredient specifications from oil trade suppliers – there’s a dearth of easily found information in the literature -  and little incentive to provide it; easy access of this information to customers would probably have a negative sales kickback (in terms of future potential usage of the ingredient) for the supplier involved.  

 

A fifteen-fold reduction of FCF’S from their present level, restricting them to 1 ppm in fragrances not washed off the skin and exposed to sunshine, would be potentially so serious for the art of perfumery since furanocoumarins occur widely across the Apiaceae & Rutaceae (see list below). Together with cuticular waxes, coumarins and polymethoxylated flavones, they make up a considerable part of the non-volatile residue of the peel oils of citrus oils like mandarin, sweet & bitter orange, grapefruit, bergamot & lime. Many of us had assumed – apparently mistakenly - that due to their relatively high molecular weights and very low vapour pressures, FCF’s would not be potentially steam distillable from vegetable material.  We have been told that this is incorrect: Daniel Joulain (Joulain 2006), for example, confirmed to Cropwatch that water/steam-distilled Malaysian rue oil (Ruta graveolens) contains over 10% of furanocoumarins (Jaacob 1989) and that he had personally supervised Jaacob’s analysis. Perhaps I now need to go into a huddle with several of my colleagues, whilst we ask ourselves some serious questions about our comprehension of the theory of steam distillation & Daltons Law of Partial Pressures!

 

Whilst analysts from the big Corporates have been fairly quick to rush out a method for the quantification of furanocoumarins in citrus oils (e.g. Frerot & Decorzant, Nov. 2004) and it is obvious from their published remarks that the authors knew this move was coming (restriction of FCF’s to 1 ppm) before many of us less well-connected aroma industry drones had appreciated it. Further, the cost of the analytical equipment needed to determine the FCF contents (HPLC coupled with UV, fluorescence & mass detection) is beyond the resources of many of us affiliated to the smaller aroma concerns. The financial exclusivity in the ability to estimate FCF’s to the cash-rich larger aroma concerns, is not healthy, and not in the overall best interests of the industry.

 

Cropwatch has attempted to quickly put together some data on natural ingredients that contain FCF’s. If readers have further information, we would be grateful if you shared it with our supporters and ourselves. Remember that under ordinary circumstances, citrus oils such as FCF-free bergamot oil are often adulterated, but that when asked, oil trade companies & organisations are hardly going to give (or be given) typical (adulterated/blended) citrus oils to submit to bodies such as RIFM to work with. This gives an artificiality to the situation, and is one of the failings of the system as it stands, which is so trade-reliant for samples and information.

 

Finally a non-scientific small sampling of UK perfumer’s views on this matter indicates that due to their position as key ingredients, if bergamot, petitgrain and coriander qualities are found to have FCF contents which subsequently interfere with their use in perfumery to a greater extent than at present, the concensus was we might as well all give up and go and work at Tesco’s.

 

Paucity of - /Conflicting Data on Phototoxic Potential of Natural Botanical Ingredients.

 

Ammi visnaga oil Ammi visnaga (L.) Lam.

CAS n°  - - -

Cropwatch comments: Commercially produced oil, used in aromatherapy.

For: Contained photochromones khellin & visnagin used to pigment skin via UV in vitiligo treatment; photochemical cross-linkage to DNA disputed by photo-sensitised DNA cleavage noted. (Chen & Kagan 1993).

 

Angelica root oil/extracts – all origins (solvent extracts often incorrectly sold as an ‘oil,’ esp. with Chinese oils). 

Angelica archangelica L. ssp. archangelica var. sativa (Miller): European oil.

A. sinensis (Oliv.) Diels. Chinese oil.

A. koreana Maxim. Contains isoimperatorium, oxypeucedanin.  

CAS n° EU 84775-71-7 (A. archangelica spp. & subspp. only).

For: Zobel & Brown (1991) show psoralen, xanthotoxin and bergapten in fruits & seeds of A. archangelica. RIFM found Angelica root oil phototoxic. Opdyke D.L.J. (1975). IFRA (2001) recommends 0.8% max. of Angelica root oil in products applied to skin then exposed to sunshine.

Against: Essential oil obtained by steam distillation of roots of A. archangelica claimed free of furanocoumarins by EMEA (1996); root & seed essential oil also claimed to be free of FCF’s therefore not phototoxic by Leung (1996).  RIFM found angelica seed oil non-photo-toxic: Opdyke (1974) through Tisserand & Balacs (1996) page 116.

 

Aniseed oil Pimpinella anisum L.

CAS n° EU: 84650-59-9

For: Plant tissues contain bergapten (Leung 1996).

Against: Steam distilled seed oil not traditionally considered phototoxic.

 

Bergamot oil cold pressed – all origins Citrus aurantium L. subsp. bergamia (Risso et Poit.) Engl.

Cropwatch comments: Bear in mind that the cultivation of the Bergamot tree (Calabria, Ivory Coast) is deceasing – perhaps partly due to the efforts of career toxicologists in reducing demand?

CAS n° EU: 89957-91-5.

For: String of earlier studies (see BoDD website) show that bergamot oil- containing perfumes are phototoxic. [Cropwatch comments:  it must be remembered that bergamot oil concentrations in fragrances were likely to be higher during this older period; voluntary restrictions on concentrations deployed since then & use of FCF type may have reduced adverse reaction frequency]. Photoxicity of bergamot oil demonstrated on mouse skin when irradiated with UV light (Opdyke 1973). IFRA restricts to 0.4% in fragrances not washed off skin, exposed to sunshine.

Against:

“Reported acute phototoxic side effects from perfumes are rare, repeated exposure to sunlight after perfume application uncommon… no reports of increase in epithelial tumour formation on areas of skin habitually exposed to perfume (Dubertret et al. 1990 & Chouroulinkov et al. through Lawrence 1991).

Bergamot oil only “known as a mildly phototoxic ingredient” (Nathalie et al. 2006).

Bergamot oil samples “can vary in phototoxic capacity” – Zanoun et al. (1974) - through BoDD.

“Despite its increasing application, there are only a few recent reports of phototoxic reactions to bergamot aromatherapy oil.” - Kaddu et al. (2001).

“Cropwatch estimates that hundreds of thousands of body massages world-wide have been given by aromatherapists using (diluted) bergamot oil, but we only know of a vanishing small number of adverse reactions. We need to understand why this is exactly.”

 

Bergamot oil Distilled.

For: Rectified oils may contain ~ 300 ppm bergaptene according to one Italian manufacturer.

Against: Up to now has been generally assumed to be non-phototoxic e.g. by S. Arctander (through Opdyke 1973).

 

Bergamot Oil FCF.

For: Contains from zero to 9-10 ppm bergaptene (Cropwatch consensus of several manufacturers).

Cropwatch comments: higher boiling fractions of distilled bergamot oil (which contain valuable odour compounds) may be treated by column chromatography, chemo-absorbtion techniques or by solvent extraction to reduce overall FCF content, and are added back to low boiling fractions (thanks to D. Joulain & staff from Italian citrus producers who don’t want to be named, for this information).

 

Carrot Seed oil Daucus carota L. subsp. carota

CAS n° EU: 84929-61-3

For: Slight photosensitising effect known from whole carrots (Ceska 1986).

Against: Not previously considered photo-toxic. Not found photo-toxic by modified 3T3 neutral red uptake assay (Nathalie et al. 2006).

 

Cedrat oil: peel oil Citrus medica L.

CAS n°:  68991-25-3.

Against: Peel oil claimed to contain negligible amount of FCF’s by certain Italian citrus oil manufacturers.

 

Celery Seed oleoresin/oil. Apium graveolens L. var. dulce (Miller) DC.

CAS n°  EU: 89997-35-3

For: FCF’s known in stems, especially if diseased.

Against: Oleoresin & solvent extracts at least, expected to contain FCF’s.

 

Clementine Terpenes (Italy) Citrus reticulata Blanco var. clementine.

CAS n°  EU: 68608-34-4

No data.

 

Coriander Leaf oil Coriandrum sativa L.

CAS n° EU : 84775-50-8

No data

 

Coriander oleoresin/oil Coriandrum sativa L.

CAS n° EU : 84775-50-8

For: Fruits contain psoralen, angelicin etc. (Leung 1996).

 

Dittany oil (syn. Gas Plant) Dictamnus albus L.

CAS n° : - - -

For: FCF’s known to occur in plant.

 

Grapefruit oil expressed – all origins Citrus paradisi Macf.

CAS n° EU: 90045-43-5.

Contains up to 1.4% coumarins & furanocoumarins.

For: Restricted IFRA to 4% in fragrances not washed off skin exposed to sunshine.

Against: Expressed oil not phototoxic: Sams (1941), Opdyke (1974).

 

Kaffir lime oil pressed/leaf oil Citrus hystrix DC.

CAS n° - - -

Against: Claimed to contain negligible amount of FCF’s by some citrus oil manufacturers.

 

Lemon oils cold pressed  - all origins Citrus limon (L.) Burm.

CAS n° EU: 84929-31-7.

For: Photo-toxicity of lemon oil cold-pressed almost totally due to oxypeudedanin & begapten; contents and ratios of these compounds varies according to origin; average bergapten ~87ppm & oxypeucedanin 26-728ppm (Naganuma et al. 1985). Opdyke (1974a) previously described lemon oil phototoxicity and IFRA currently recommends limit of 2% in fragrances not washed off skin exposed to sunshine.

 

Lemon oil Distilled.

No data

 

Lemon Oil Terpeneless

No data

 

Lemongrass Oil West Indian Cymbopogon citratus (DC) Staph.

CAS n° EU: 89998-14-1.

For: Slightly photo-toxic for C. citratus (as shown by modified neutral red uptake assay: Nathalie et al. 2006).

Against: We have: E.I. & W.I. lemongrass oils found non-photo-toxic Opdyke D.L.J. (1976) FCT 14, 455 & 457.

Other statements: W.I. Lemongrass oil phototoxicity ‘has not been determined’ Opdyke (1976) through Leung (1996). E.I. Lemongrass phototoxicity ‘is not known’ Opdyke (1976), again through Leung (1996).

Cropwatch comments: We’re confused!

 

Lime oils cold pressed – W.I.: Key or Mexican lime Citrus  x aurantiifolia (Christ.) Swingle, & Persian or Tahitian lime C. latifolia Tanaka. 

CAS n° EU: 90063-52-8.

For: FCF content noted by Pathak (1962). IFRA (1992) limits to 0.7% in fragrances not washed off skin exposed to sunshine based on Opdyke (1974b) its bergapten content as reported in J.A.O.A.C. (1969) 52(4),727.

 

Lime oil distilled.

Against: Distilled lime oil is not photo-toxic (Tisserand & Balacs (1996) p147, quoting Opdyke 1974).

 

Lime oil terpeneless.

No data

 

Limette peel oil Citrus limetta Risso

CAS n° - - -

 

Mandarin oils - cold pressed Citrus reticulata Blanco.

CAS n° 84929-38-4.

For: IFRA advises typical 5-MOP content of cold-pressed mandarin oil is 250 ppm.

 

Mandarin oil folded Citrus reticulata Blanco.

No data found

 

Neroli oil C. x  aurantium L. flowers.

CAS n° EU: 72968-50-4.

For: Phototoxic reactions to oil reported historically (Greenberg & Leicester 1954 - through BoDD).

 

Orange Peel oil, Bitter Citrus aurantium L. subsp. amara L.

CAS n° 68916-04-1

For: Based on RIFM work, IFRA limit of 1.25% based on uncertainty factor imposed over data of Kaidbey & Kligman (1980).  

 

Orange Peel oil Sweet Citrus sinensis (L.) Osbeck

CAS n° USA: 8008-57-9

For: ‘Probably phototoxic’ (as shown by modified Sudan Red uptake assay) Nathalie et al. (2006). Peels contains bergapten.

Against: Not phototoxic, not restricted IFRA.

 

Orange oil sweet folded Citrus sinensis (L.) Osbeck

No data found

 

Orange oil sweet terpeneless Citrus sinensis (L.) Osbeck

No data found

 

Parsley herb/seed oils/oleoresin Petroselinium crispum (Miller) A.W. Hill.

CAS n° EU: 84012-33-9

For: Toxicity associated with furanocoumarin content Newall et al. (1996).

IFRA advises that typical 5-MOP content of parsley leaf oil is 20 ppm.

 

Parsnip extracts/oil Pastinaca sativa L.

CAS n° EU: 90082-39-6

For: Tissues contains bergaptene, xanthotoxin, angelicin, sphondin, isopimpinellin, imperatorin.

 

Petitgrain Bigarade oil C. aurantium / C. aurantium v. aurantium  leaves.

CAS n° EU: 72968-50-4.

For: Phototoxic reactions to oil reported (Greenberg & Leicester 1954, Klarmann 1958 – through BoDD).

Against: Petitgrain oil not phototoxic: RIFM monograph FCT 20, 801 Sp Issue VI.

Cropwatch comments: in real life, other Petitgrain oils: mandarinier, citronnier, bergamottier, are often of variable composition (blends of several oils).

IFRA advises that typical 5-MOP content of Petitgrain mandarin oil is 50 ppm.

 

Rue oil Ruta graveolens L.

CAS n° EU: 84929-47-5

For: Jaacob (1989) through Joulain (2006): steam distilled Malaysian rue oil contains psoralen (1.3%) and bergapten (7.2%).

IFRA limits rue oil to 0.15% in fragrances not washed off the skin exposed to sunshine.

Cropwatch comments: rue oil is not much used in perfumery.

 

Satsuma oil (Japan, USA) Citrus unshiu Marc.

No data

 

Skimmia laureola oil India, Kasmir Skimmia laureola Sieb. et. Zucc. ex Walp.

Cropwatch comments: steam distilling leaves yield oil produced on commercial scale, which has been compared as similar in odour to petitgrain.

CAS n°: - - -

For: 25 Psorelens & coumarins amongst identified FCF’s (Pathak & Pant 1977; Radzan et al. 1986). Acetone extract of dried leaves yields bergatene, xanthotoxin etc. (Bhargava et al. 1973).

 

Star Anise Oil Illicium verum Hook f.

CAS n° 84650-59-9.

Against: Not previously found phototoxic to mice & swine (Opdyke 1975).

 

Sweetie oil Citrus paradisi x Citrus grandis

CAS n° - - -

No data.

 

Tangerine oil – cold pressed Citrus reticulata Blanco var. mandarin

CAS n° EU: 93686-22-7.

For: IFRA advises typical 5-MOP content of CP oil is 50 ppm.

Against: No FCF monomer/dimer found in 12 tangelos & 2 monohybrid tangerine varieties frown in Florida (Widmer 2005).

 

Yuzu oil – cold pressed Citrus junos Sieb. ex Tanaka)

CAS n° USAS: 233683-84-6.

No data.

 

It is reasonably obvious that the SCCP need to look further into this veritable Pandora’s box that they have just opened – getting the lid back on may prove pretty difficult. Basically it is evident that the SCCP haven’t realized the scope of the implications of their ‘Opinion’, or are happy to relegate perfumery to an increasingly synthetic future.

 

Several of you are suggesting that the combination of the EU’s obsession with the precautionary principle, continual negative advice from the advising ‘career toxicologists & dermatologists’, the complete inability of ‘expert’ committees to evaluate the benefit side of the risk-benefit equation, together with he complicity of essential oil trade organisations in supplying requisite data to EU legislators, has now reached the point of extinction for the continued well-being of industry at the user-end of aromatic products. Some are suggesting the establishment of ‘an alternative’ voluntary regulatory authority, with a better appreciation of the predictable consequences of proposed ingredient regulation, as this ability is evidently missing in the present system.

 

Whilst we haven’t examined the implications of the SCCP/0942/05 Opinion, in any great detail for what is left of the perfumery industry, Cropwatch is open, in principle, to debate & suggestions on a better way to regulate natural product usage in Cosmetics, Perfumery, Natural Perfumery, Biocides, Aromatherapy, Herbalism etc. In our opinion, it is apparent that the present regulatory system has failed - it does not command universal respect, the ‘expert’ committees produce work that is both incomplete & often seriously flawed, and those that oversee the Opinions are insufficiently expert across the broad range of skills required to do the job properly. Further, those bodies many of us formerly regarded as reasonably independent (like IFRA), are now seen as part the EU “big brother” diktat mentality. The culture of corruption in the EU and the way that whistleblowers are dealt with is hardly a new subject (see for example Eurosoc Two 2004). We think that the deliberate attempts to sideline & ignore Cropwatch and not to take its ‘awkard’ opinions on board over the past year by the machinations of the EU regulatory machine are now sufficiently advanced that Cropwatch can prepare its case for presentation to the Ombudsman.

 

This aside, could another body do the job better? - we think that it could, but this would depend on a critical mass of support being established. The rate at which this support is being pledged to Cropwatch is encouraging, but we do need you professors, doctors, technicians, students and most of all, you ordinary folk, interested in the natural aromatic products area, to contribute & continue help us grow. 

 

References:

Bhargava K.K. & Seshadri T.R. (1973) Current Sci 42, 59-60.

 

Ceska O. et al. (1986) “Furanocoumarins in the cultivated carrot, Daucus carota. Phytochem. 25, 81-3.

 

Chen X. & Kagan J. “Photo-sensitised cleavage & cross-linking of pBR322 DNA with khellin & visnagin” J. Photochem. & Photobiol. B: Biology  20(2-3), 183-189.

 

Chouroulinkov I., Lasne C. & Nguyen-Ba (1989) “Study with 5-MOP, bergamot & Bergasol in mouse skin carcinogenicity tests. In Psoralens: Past, Present & Future of Photochemoprotection & other biological activities.” Eds: T.B. Fitzpatrick, F. Forlot, M.A. Pathak & F. Urbach pp345-355. John Libby Eurotext. Paris.

 

Dubertret L., Serraf-Tircazes D., Jeanmougin M., Morliere P., Averbeck D. & Young A.R. (1990) “Phototoxic properties of perfumes containing bergamot oil on human skin. Photoprotective effect of UVA and UVA substances.” J. Photochem. Photobiol. B: Biology. 7, 251-259.

 

EMEA (1996): Committee for Vertinary Products May 1988 (ref EMEA/MRL/412/98-FINAL. Root & seed essential oil also claimed to be free of FCF’s by Leung (1996). 

 

Eurosoc Two (2004) “Watching Big Brother” – see www.eurosoc.com/news/

 

Frerot E. & Decorzant E. (Nov 2004) “Quantification of total furanocoumarins in citrus oils by HPLC coupled with UV, flouresence, & mass detection.” J. Agric. Food Chem. 52(23) 6879-86.

 

Greenberg L.A. & Lester D. (1954) Handbook of Cosmetic Materials. Interscience NY.

 

Jaacob K.B. et al.  (1989)  J. Essent. Oil Res. 1, 203.

 

Joulain D. (2006): Private communication to author.

 

Kaddu S., Kerl H., & Wolf P. (2001) “Accidental bullous phototoxic reactions to bergamot aromatherapy oil.” J. Am. Acad Dermatol 45(3), 458-461.

 

Kaidbey, K.H. & Kligman, A.M. (1980). “Identification of contact photosensitizers by human assay.” Current Concepts in Cutaneous Toxicity, 55-68. Academic Press, NY. Report No 1995.

 

Klarmann E.G. (1958) “Perfume Dermatitis” Ann. Allergy 16, 425.

 

Lawrence B. “Progress in Essential Oils” Perf. & Flav. Vol 10 Sept/Oct 1991 p78.

 

Leung A.Y. & Foster S. Encyclopaedia of Common Natural Ingredients used in Food, Drugs & Cosmetics 2nd edn. Wiley-Interscience pub. 1996.

 

Nathalie D., Yannik G., Caroline B., Sandrine D., Claude F., Corrine C., Pierre-Jacques F. “Assessment of the Phototoxic Hazard of Some Essential Oils using Modified 3T3 Neutral Red Uptake Assay.” Toxicol in Vitro 20(4), 480-489.

 

Opdyke D.L.J (1973) Food Cosm.Toxicol 11, 1035.

 

Opdyke D.L.J. (1974) Food Cosm.Toxicol 12, 723.

 

Opdyke D.L.J. (1974a) Food Cosm.Toxicol 12, 725

 

Opdyke D.L.J. (1974b) Food Cosm. Toxicol. 12, 731

 

Opdyke D.L.J. (1975) “Angelica Root Oil” FCT 13, (Suppl), 713.

 

Pathak H.D & Pant J.N. “Chemical examination of Skimmia laureola Sieb. & Zucc. Indian Perf. 16(1), 454-50.

 

Pathak, M.A., Daniels, F. and Fitzpatrick, T.B. (1962) “Presently known distribution of furocoumarins (psoralens) in plants”. J. Invest. Derm. 39, 225.

 

Radzan T.K., Qadri B., Harkar S. & Waigt E.S. (1986) “Chromones & Comarins from Skimmia laureola.” Phytochem. 26(7), 2063-2069.

 

SCCP Opinion on Furanocoumarins in Cosmetic Products (SCCP/0942/05) – available at  www.europa.eu.int%00/comm/health/ ph_risk/committees/04_sccp/docs/sccp_q_042.pdf

 

Tisserrand R. & Balacs T. (1996) Essential Oil Safety for Health Professionals

Churchill Livingstone.

 

Widner M. 2005 “Tangerine/grapefruit Hybrids (Tangelos) do not have Furanocoumarins Associated with Grapefruit/Drug interactions” J Food Sci. 70(4), 307-312.

 

Yaacob K.B. (1989) et al. J. Essent. Oil Res. 1, 203.

 

Zanoun S., Hall I., Johnson B.E. & Frain-Bell W. (1974) “A study of bergamot sensitivity” Brit J. Derm. 91(Suppl 10), 14.

 

Zobell A.M. & Brown S.A. (1991) “Furanocoumarin concentrations in fruits and seeds of Angelica archangelica” Environmental and Experimental Botany 31(4), 447-452

 

 

SCCP Opinion on Furanocoumarins in Cosmetic Products (SCCP/0942/05) – available at

 

www.europa.eu.int%00/comm/health/ ph_risk/committees/04_sccp/docs/sccp_q_042.pdf

 

 

 

 

#1. Sandalwood Oil Update.

The threatened ecological status of sandalwood (Santalum album L.) has largely gone unheeded by the wealth creators (trade suppliers) & consumers of the precious wood and the East Indian distilled oil, who continue to buy and trade sandalwood commodities. It hasn’t been difficult to spot the problem coming either – during the on-going task of researching entries for the Cropwatch sandalwood data-base (see http://www.cropwatch.org/sandalwoodbib.htm), we unearthed the massive bibliography of M.S. Ross (unpublished, 1983) who noted that “the literature in fact is dominated by articles on sandalwood spike disease”. Official India govt. trade figures are starting to reflect the gravity of the supply situation, with wood production down from 4000 tons in 1950 to a mere 70 tons in 2004. Timber & oil production figures (t/annum) are as shown:

 

 

Year

Sandalwood

production

Sandal oil

production

Sandal oil exports

1950

4000

150

90

1970

2500

100

60

1980

2000

80

50

1990

1200

50

30

2000

1600

30

10

2004

70

-

-

 

 

Adapted from: Parfums Cosmetiques Actualites No 187, Feb/Mar 2006 p32 (figures ascribed to FAFAI Journal Oct-Nov 2004: “Manufacturing of Sandalwood oils Market Potential, Demand & Use”). 

 

[These figures shouldn’t be taken as being any too accurate, since sandalwood oil is extensively smuggled out of India using a variety of routes].

 

Sandalwood in Perfumery.

A handful of the more ethical fragrance companies have stopped using East Indian sandalwood oil completely, realising that both perfumery and aromatherapy are still actually possible without this ingredient! Formulators are starting to write sandalwood oil out of new fragrances because the message about its poor availability is getting through; some have played with substituting the more poorly odoured (more woody-resinous smelling) solvent extracted Australian ‘oil’ from Santalum spicatum.  

 

Sandalwood Users in Aromatherapy. As you can see from the figures, the excuse that sandalwood oil producers & users have given up to now, that oil volume figures are miniscule in proportion to volumes of exported wood, is no longer viable. In a world now much more concerned about global warming, you would have thought that the high carbon footprint of sandalwood production alone, might surely have been enough to cause concern (steam distillation of individual batches requires 100 to 120 hours of distillation, or longer if distilled is carried out under reduced pressure. Worse than this, production of sandalwood attars can take 2-3 weeks). We have never seen this point taken on board by any aromatherapy body we have suggested it to. 

 

Individual founders of Cropwatch have also been arguing for several years now with professional aromatherapy bodies (such as the UK’s self-appointed Aromatherapy Consortium) to use their influence to see that teachings about sandalwood oil in aromatherapy are curtailed, in order to try to reduce demand for the commodity. ITEC, the commercial business organisation that styles itself as “the largest international examination board offering a variety of qualifications worldwide”, providing “government accredited qualifications”, still recommends the study of sandalwood oil East Indian – see for example the ITEC Level 3 syllabus page for Aromatherapy at http://www.itecworld.co.uk/Itec?005Syllabus/Aromatherapy/Aromatherapy%20Syllabus.pdf . On this page, amongst a huge number of (presumably government non-accredited?) scientific mistakes, you will also see that the two principle components of sandalwood oil are said to be ‘santene’ and ‘santalol’ [hmm - so much for UK aromatherapy education standards!].

 

The clear light of ecological correctness therefore has still to filtrate through to much of the aromatherapy community, which unfortunately relies on misleading sales hype from essential oil traders for much of its information. Organisations such as the Ipswich (UK) based Aromatherapy Trades Council (which Cropwatch estimates represents just 5-6% of the total number of UK aromatherapy oil sellers) made what we regard as face-saving statements following its 2004 AGM about policies wrt threatened aromatic species, but the reality is, that this ploy has failed to change the behaviour of some of its constituent members, who continue to offer sandalwood oils (or the similarly threatened Brazilian rosewood oil) to anyone who will buy. 

 

Sandalwood in Academia. In some places, academic awareness of the dire ecological status of Sandalwood supplies appears to be no better informed.  Braun et al. (2005) – see Cropwatch data-base – entitle a published paper “New Caledonian Sandalwood – a Substitute for East Indian Sandalwood Oil?”. How they think that the world demand for sandalwood oil – conservatively estimated at 200 t/annum but probably in reality up to ten times that figure, could possibly an be met by New Caledonia’s miniscule production of oil from Santalum austrocaledonicum Veill. ssp. austrocaledonicum (possibly 1t/annum) is beyond Cropwatch’s comprehension. What will probably happen in practice, is that New Caledonia will be depleted of Sandalwood trees at an even quicker rate than otherwise would happen, and we can already name essential oil suppliers helping to do just this very thing. If you can forgive us a little frustrated sarcasm, “thanks, guys”.   

 

 

#2. Tagetes Oil.

 

The EU has a clear duty to consult independent experts and to fund independent science in its construction of a plausible Chemicals Safety Policy. But in the same breath, neither should EU Directives be constructed largely around the views of a handful of academics or scientists – most of us, surely, ascribe to the oft-quoted view that “dialogue about science is an essential component of a well-oiled democracy”. But it is often hard to see any evidence of public participation or for that matter, truly independent science, in issues surrounding the regulation of most natural products. 

 

We can return to the thorny subject of scientific independence at a later date (in the meantime see articles highlighting the problem such as  http://www.thenation.com/doc/20020805/newman20020725). For now, lets consider the developing regulatory prejudices around the tagetes oil situation.

 

Cropwatch has already established in its Opinion to the SCCP that no convincingly substantive record of proof of phototoxicity from either tagetes plants or commodities containing tagetes oil is noted in the scientific literature. In spite of this, those professional researchers whose continuing employment depends on the emphasis of the precautionary principle and advanced toxicological modelling techniques seem determined to trample any dissenting opinion into the dust, apparently with a nod and a wink from DG Sanco. 

 

In the interests of openness and freedom of information, Cropwatch understands that RIFM is experiencing problems with human phototoxicity studies on Tagetes extracts used in perfumery (the no effect limit was previously established by RIFM in 1983 at 0.05%, but more modern phototoxicity indicator tests, such as ‘3T3’ tests – more on this later if you don’t know what this technique involves - don’t usefully give a no-effects limit). A recent communiqué by EFFA to its corporate membership also disturbingly informs that “the Fragrance Industry” will provide analytical data on qualities of Tagetes used in perfumery.” Lets be quite clear about this - the trade organisation EFFA does not speak for, nor represent “the Fragrance Industry”.  At best, it represents a certain fraction of it. Neither is it the sole mandate of EFFA to present analytical data in this area - anyone reading this could easily be led to believe that the whole issue was about to be privately agreed in a cosy relationship between RIFM, EFFA  & DG Sanco. Perhaps we’ve jumped to the wrong conclusion, but we were actually under the impression that we were supposed to be living in a democracy.

 

Cropwatch still strongly believes that there is no case to answer with the tagetes oil phototoxicity issue, with respect to changing IFRA’s original recommendations of a 0.01% concentration limit on tagetes oil for non-rinse off products – which anyway seems to be within the typical perfumers’ preferred use-pattern for the ingredient. It is difficult to see what can be done further to convince the involved scientists to abandon their treasured scientific models to manufacture evidence, in favour of finding actual evidence, but following this, Cropwatch is now committed to an adverse reactions survey amongst end-users of tagetes oils. Perhaps that will finally prove beyond a doubt that ‘no case to answer’, actually means ‘no case to answer’.

 

 

#3. Kava-kava

 

Whilst we learn that 3.5 million people seem to have little difficulty obtaining Prozac in the UK (19 million prescriptions apparently written for selective serotonin uptake inhibitors or SSRI’s in 2003 – see for example http://www.timesonline.co.uk/article/0,,2-1391879,00.html ), a potentially very much smaller number who might wish to use the natural product kava-kava, haven’t fared so well.  Cropwatch first wrote to the UK’s MHRA on this subject on the 13th August 2005, asking for the transcript of the meeting which lead to the publication of the prohibition order against kava products. After eight months of chasing, we were eventually told in a mail from Judith Thompson of the MHRA (12th April 2006), that a full report on the situation is being produced and is likely to be published in mid-May (we will update the Cropwatch website as soon as we have any new information). Fearing this report will not be the transcript of the meeting we originally asked for, we have re-written to the MHRA… and we can report back (predictably) that nothing further has come of this.

 

Meanwhile Cropwatch has been trying to contact kava-kava scientific experts to hear their side of the story, fearing that the international ban on kava-kava is more likely to be a politically motivated, rather than a purely scientific, decision. In the meanwhile here is your chance to interactively contribute to a feature here – we are trying to establish a diary of events which lead up to this situation. The first draft of the events is listed below – please forward any additions, rewrites or errors to Cropwatch!

 

 

 

 

 

Kava-Kava towards a diary of events.

 

Jan 16th 2001

 Canada

 

Health Canada issues advisory announcing the department's intention to conduct a safety assessment as a result of worldwide reports of liver toxicity associated with the herbal ingredient kava.

November 2001

 Germany

 

 

German researchers allege 30 cases of liver toxicity amongst individuals taking kava.

 

 

Dec 19th 2001

 USA

 

 

FDA sends letter to health professionals to ask help in determining whether there is a problem with kava-kava, & seeking a review of ‘cases of liver toxicity to determine if any may be related to use of kava-containing dietary supplements (this information presently unsubstantiated by Cropwatch).

 

March 25th 2002

 USA

 

:

FDA Consumer Advisory issues notice stating that kava-containing dietary supplements may cause liver injury – see http://www.cfsan.fda.gov/%7Edms/addskava.html 

July 2002

 Australia:

The Adverse Drug Reaction Unit of the Therapeutic Goods Administration (TGA) reports a death from liver failure associated with kava-containing medicine. Voluntary recall of all kava-containing medicines instituted in conjunction with complimentary medicines industry. See http://www.tga.gov.au/cm/kavafs0504.htm

 

Aug 2002

 Canada

 

Canada: Health Canada issues a stop-sale order for all products containing kava.

 

2002

 

 

 

 

 

 

 

Germany, amongst seven other countries (including France, Switzerland & Canada above) bans kava drug sales following superficial enquiry on drug safety. 

 

Nov 29th 2002

 

 

 

 

 

 

CDC sums up hepatic toxicity evidence 1999-2002 in US, Germany & Switzerland at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5147a1.htm

2002

 UK

The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 No 3170 comes into force: affects sale, supply or importation - see http://www.opsi.gov.uk/si/si2002/20023170.htm

 

 

 

2002

Scotland

The Kava-kava in Food (Scotland) Regulations proposed. 

 

2002

Wales

Kava-kava in Food (Wales) Regulations 2002, proposed ban was ‘in error’, and not notified according to provisions of EC Directive 98/34/EC, & rules of Informn. Society Services OJ No. L204 21.7.1998 p37 as amended by EC Directive 98/48/EC (OJ No. 217, 5.8.1998) and so…

 

13th Jan 2003.

 UK

UK Ban on Kava-kava came into force in shape of Kava-kava in Food Regulations (2002).

 

2003

Wales

Wales revokes ban on kava-kava in Kava-kava in Food (Wales) (Revocation) Regulations 2003, replacing the 2002 regulations. Welsh kava sellers take advantage of situation to continue trading… 

 

Aug 2003

Australia

CMEC (Australia) considers KEG report and recommends to TGA only certain forms of kava suitable for use in Listed medicines. TGA accepts recommendations & Therapeutic Goods Regulations re: Piper methysticum amended accordingly: limit on the max amount of P. methysticum permitted per dosage form – tablets/capsules 125mg of kavalactones max.,  and for a tea bag 3g max. limit dried rhizome of P. methysticum). In addn, products containing P. methysticum must comply with a maximum daily dose of not more than 250mg of kavalactones – see http://www.tga.gov.au/cm/kavafs0504.htm.

 

October 2003

WHO announces it is re-evaluating position on kava-kava after the first meeting of the Advisory Committee on Safety of Medicinal Products, held in Geneva in October, following bans by several countries.

 

 

November 2003

 UK

UK: Jenny Seagrove (actress) & National Association of Health Stores takes the Secretary of State for Heath (UK Govt) to court….(see Dec 19th 2003 below).

 

Nov 2003

Wales

Welsh National Assembly overruled a ban on the herb brought by the UK's Medicines Control Agency in December last year.

 

Dec 19th 2003

 UK

UK: Justice Cane (case no CO/1888/2003) at Royal Courts of Justice decides not to overturn UK ban on kava-kava. FSA has to reconsult on the food ban (wrt goods in transit).

 

 

2003

 UK

UK: Prof. Ernst (member of MCA/MHRA) speaking at a symposium organised by Exeter & Plymouth Universities is reported as saying that the MCA failed to carry out proper risk-benefit analysis on kava-kava. He should know – he was at the meeting!

 

 

December 2004

 

Pacific: International Kava Conference in Suva, Fiji dossier on kava safety presented by participating scientists

12th May 2005

 Germany

 

German authorities (BfArM) find for the producers of kava products by letter, lifting ban “for reasons of appropriateness”. But products not put back on shelf – kava registrations put on hold because of lack of proofs of anxiolytic efficacy of individual kava products. Producers asked to provide new data by June 2007.

 

2005

Wales

Kava-kava in Food (Wales) Regulations 2005 proposed – see www.food.gov.uk/multimedia/pdfs

2005 (Autumn-Winter)

 

According to Yee (2006), PayPal blacklists kava-kava producers – apparently because of outdated FDA website advice.

 

(projected) mid-May 2006

 UK

MHRA expected to publish ‘full document’ on kava-kava.


 

#4. Pesticides.

Following the dialogue on pesticide exposure and childhood cancer etc. in the UK media, Cropwatch has attempted to summarise some of the articles which have recently appeared at http://www.cropwatch.org/pesticides.htm which includes a letter from Prof. Nick Price, pulling us up on a few points in a previous newsletter. Going on from there, Cropwatch has started a data-base on pesticides in essential oils and natural aromatic products at http://www.cropwatch.org/pesticidesdbase.htm although it hasn’t been easy for us to locate published articles - what we have found so far, mainly appears to relate to mint and citrus oils.

 

On UK’s Radio Four on Easter Sunday at 12.30 p.m. the Food Programme introduced by Sheila Dillon revealed that the pesticide Lindane (banned in Europe) has been found recently in white chocolate, 11 years after the only previous study showed that 81% of samples also contained it. Whilst Cropwatch is trying to track down the source & accuracy of this information, we are also interested in any data for cocoa absolute used in perfumery, and chocolate extracts used in food flavourings. Any offers, anyone?

 

 

 

#5. GM Artemisinin.

Jay Keasling et al. at Univ of California, Berkley have apparently succeeded in producing artemisinin from the pre-cursor artemisininic acid which is exported from GM yeast cells grown in bio-reactors, according to a recent paper in Nature. This development apparently bypasses the waiting-time necessary for its production & isolation from the Chinese herb Artemisia annua. Another triumph for the pharmaceutical industry? Well, certainly a potential chance for some short-termist profit taking!

 

For some reason, Keasling’s exploits easily create media attention; he was previously amongst a team that published a paper on bio-engineering the malevonate pathway in Escherichia coli to produce high value terpenoids (such as amorphadiene, an olefinic precursor to artemisinin) (Martin et al 2003). Although uses of higher valued terpenoids are mentioned in passing with respect to fragrances & flavours, presumably the authors quickly came to understand that GM produced terpenoids are not acceptable in food & feed flavourings, and may even be prohibited by law in certain countries. Cropwatch cannot see why any different set of criteria should apply to GM produced drugs. In any case, as previously covered by Cropwatch, the ‘magic bullet’ (monotherapeutic) approach to tackling malaria is predicted to fail after a few years, as resistance to artemisinin grows – we will then have major antimalarial drugs to fall back on.

 

If you think you can detect Bill Gates’ hand in all this – you would be right. According to Sample (2006), the Bill & Melinda Gates Foundation gave $43 million to the researchers to develop low-cost drugs to treat malaria using GM microbes. Nobody would argue that the eradication of malaria was not one of the most noble goals for mankind to achieve imaginable, but whether using GM technology to try to achieve this will find any sort of widespread acceptability is quite another matter. 

 

References.  

 

Martin V.J.J., Pitera D.J., Withers S.T.,

 

Newman J.D. & Keasling J.D. (2003) “Engineering a mevalonic pathway in Esherichia coli for the production of terpenoids”  Nature Biotechnology 21, 796-802.

 

Sample I. (2006) “GM yeast cells offer ‘last line of defence against malaria.” The Guardian 13th April 2006 p14. 

 

#6. Gunns Sues Environmental Campaigners.

Gunns, described as the biggest logging and wood-chip company in Australia, is reportedly sueing 20 environmental campaigners for A$6.8 million who have, it is alleged, committed unlawful actions in protesting about wrongdoings by Gunns (who are busy logging down & then napalming ancient forests in Tasmania). This particular episode reminds of McDonald’s previous doomed attempts to silence protesters, according to a group of some forty British lawyers who wrote to The Guardian letters page (Starmer et al. 2006) protesting against legal moves by Gunns which they described as an attack on freedom of speech & freedom of assembly.  Cropwatch has previously featured Gunns seemingly unstoppable activities in whichever country they choose to operate, and the close relationship that senior Tasmanian politicians have with the company (see “Tasmania: destruction of a forest eco-system” at http://www.cropwatch.org/cropwatch3.htm ).

 

For background, and for campaign updates on the state of play wrt Gunns activities, please visit the Wilderness Society at http://www.wilderness.org.au/campaigns/corporate/gunns/whatisgunn/

 

Reference.

Starmer K, QC et al. “Tasmanian action a threat to human rights” Letters, Guardian Mon April 3rd 2006.

 

#7. REACH and Natural Products of Botanical Origin

Cropwatch has not covered this topic before, mainly because it gives the team a dangerous level of apoplexy just to start to think about it. We are not experts in this area (like most of the general public), and due to the secretive nature of how the detailed machinations of this type of regulation actually work in practice, we only get thrown scraps of information from time to time. We’d appreciate any corrections, improvements or offers of help in order to get this across to a wider public (but please, we are allergic to industry hype!).

 

In October 2003 a new regulatory framework for Registration, Evaluation & Authorisation of Chemicals (REACH) was proposed by the EU Commission. The aim “is to improve the protection of human health and the environment through the better and earlier identification of the properties of chemical substances.” REACH really goes back to the EU Commission’s (2001) White Paper on a “Strategy For a Future Chemicals Policy”. You guessed it: as usual, the manufacturers have to provide all the safety information and give it to the EU, & swallow all the involved costs.

 

According to http://europa.eu.int/comm/enterprise/reach/index_en.htm : “The first reading in the European Parliament took place on 17 November 2005 (Provisional amendments (2005) 0434 and (2005) 0435) and the political agreement in the European Council on 13 December 2005 (REACH, Council text and Directive 67/548/EEC, Council text). After a final adoption of the REACH legislation, which is expected by the end of 2006, it can be estimated that the entry into force of the REACH-legislation will be around April 2007. The new European Chemicals Agency has to be fully operational 12 months after entry into force of the legislation.” Some 390 amendments (out of 1050) were adopted in the first reading. 

 

So how does this affect natural aromatic materials? We can sum it up in one word. The word is: Badly.

 

Briefly, to backtrack, representatives lobbying for the essential oils trade (especially Herculean efforts made by EFEO) begged that, in a proposed amendment to the REACH draft Regulation (Doc. COM (2003) 0644-(03), Volume 1 Title I Chapter II Art.3 and Volume II, Annex III, section 8) – pause for breath! - that botanically defined substances are exempt from the obligation to register in accordance with article 4 (2) (b) – sorry about this! – in Volume II, Annex III section 8. Further a botanically defined substance under new paragraph 1a – nearly finished! – under Volume I, Title I, Chapter II, Article 3 (definitions) would give: “A botanically- derived substance means a complex substance obtained by subjecting a plant or its parts to a physical treatment such as extraction, distillation, expression, fractionation, purification, concentration or to fermentation. Their compositions vary depending on the genus, species, growing conditions of its source and the process used for its treatment.”

 

Sounds reasonable doesn’t it? Well, they lost – it transpires that botanical extracts are not exempt, but there is an exemption for flavouring materials through EC Directive 88/388. What has made Cropwatch supporters particularly angry, is that under additional materials – turpentine oil - produced in the range 100 to 1000 t/annum - is (oh so curiously!) exempt. Supporters believe this is most unfair, and is indicative of the power of unseen influential lobbying that goes on behind the scenes. After all, natural botanically defined substances (which are basically very largely low volume materials), are already sufficiently regulated in their applications, by Directives such as:

 

Biocides Directive 98/8/EC

Cosmetics Directive 76/768/EEC

Detergents Regulation 648/2004/EC

Feeding stuff Directive 70 /524/EEC

Foodstuff Regulations 178/200/EC

Flavouring Directive 88/388/EC

Pharmaceuticals Directive 83/2001/EC,

Traditional Medicines Directive 24/2004/EC,

 

Now fragrance organization are encouraging members to pre-register/register all fragrance materials (both chemically defined and natural complex substances) produced at a volume of over 1 ton /annum to the Chemicals Substances Agency (of which maybe approx. under 150 are natural). For substances in the 1-10 ton category only human health & environmental data is required unless predicted (by available data or QSAR predictions) to have CMR properties (Carcinogenic, Mutagenic & Reproductive), PBT (Environmentally Persistant, Bioacummulative & Toxic) or vPvB (very Persistent & very Bioaccumulative) and classified as dangerous and intended for consumer use (most aroma chemicals). In the 10-100 ton band reproducible and developmental toxicity data requirements may be waived. Amongst a number of other miscellaneous points, registration time limits for R50/53 substances is foreshortened, the principle of one substance, one registration etc. is accepted and 3rd parties can represent an individual company/consortium.

 

As acutely interested bystanders, the questions Cropwatch has, include how many natural botanically defined materials produced at over 1 ton are not going to be revealed/supported by major trade fragrance organizations feeding into the Chemical Substances Agency. Since EFFA/EFEO etc. only represent a fraction (admittedly a significant fraction, but nevertheless still a fraction) of essential oil users and producers globally, what provisions are there to cover the ‘non-trade organization members’ end of this equation (presumably none?). Further, how do the general public (or non-members of EFFA etc.) obtains information on CMR, PBT and vPvB properties (if say, they haven’t got access to helpful documents such as IFRA’s publication IL 680). Where is the level playing field in this matter when non-trade organization members are disadvantaged with virtually zero information? Further, if aroma traders wish to register a material but cannot afford the techniques based on the QSAR approach, does this not mitigate against small producers? And how will these regulations affect essential oil users – aromatherapists, the large number of natural perfumers (as opposed to corporate perfumers) etc?

 

It just seems that that the Brussels “rich-mans club” is getting more and more elitist, distant & exclusive, and there is a whole “left out” culture not covered or even informed of these rapidly progressing developments. Perhaps Cropwatch could start to gather these unfortunates beings together… at least we don’t have membership charges!

 

#8. Tea Tree Oil.

As the June 2006 deadline approaches, Cropwatch is in the process of gathering in its completed adverse reaction to tea tree surveys, to forward to the SCCP. Although it was initially feared that a computer crash in March 2006 would result in some loss of data, we have been able to recover it.

 

The on-line Cropwatch tea tree survey was originally designed to show up any clusters of adverse reactions from customers of a certain company who, we were informed, was apparently selling deliberately oxidised tea tree oil with the misguided intention that it was more desirable as oxidised tea tree is more anti-microbial (but failed to appreciate it is potentially more allergenic). Following an appeal for more information on this matter via a general circular to its supporters, Cropwatch now knows the identity of this company, and will take legal advice on the best way to proceed if enough adverse reaction data filters through from the tea tree surveys.

 

Many thank-you’s to those of you who have filled in a survey and those of you who have spread the word.
 
Special thanks to UK based IFA (International Federation of  Aromatherapists) members who returned more than 70 completed surveys and to U.S. based AromaticsInAction whose members have also been very supportive including inviting us to talk about the issue on their monthly tele-conference which was very enjoyable. Extra – special thanks also to Kelly at NAHA for her unfaltering efforts with publicising Cropwatch and the TTO survey.  There are still a few weeks left for anyone still wishing to contribute to the cause by way of giving a few minutes to complete the form which is at
http://www.cropwatch.org/TTOsurveyclick.htm
 
Thanks too to the efforts of Dietrich Wabner who has run with the Cropwatch-designed interactive form himself and got a good many responses – every bit helps.  We will be sharing data findings with the ATTIA TAS committee and Dietrich in order to deliver as comprehensive a portfolio as possible to the SCCP but the Independently analysed results of our survey will be made publically available as soon as we have them.

 

 

 

Held-over Topics.

The promised ‘Indoor Air Quality’ review, and ‘Coumarin – the Real Story’ are held over for while, as other matters have swamped our limited resources!

 

More next time.

 

The Cropwatch Team.