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The Peru Balsam Fiasco.
Revised & Updated
Copyright Ó Cropwatch Sept.2005 - April 2006
Skip to Update April 2006
Skip to Further Update
Pre-amble.
It must be very frustrating for the officials of aroma trade organizations who have to be polite and respectful to officials who have totally screwed-up over an EU fragrance ingredient Regulatory issue, with unfortunate (but hopefully short-term) consequences for an already beleaguered industry. Such a situation now faces the trade, and not for the first time.
Crude Peru Balsam, according to Burfield (2005) is:
“…produced by slashing and removing strips of the scorched and wounded bark of the tree Myroxylon balsamum (L.) Harms var. pereirae (Royale) Harms syn. M. pereirae (Royle) Klotzsch that grows to 25m. It is produced mainly in El Salvador, with some former production in Guatemala and Honduras. Sometimes trees are individually worked to give several (usually 3) tappings, and the exudate is collected on rags, which are subsequently boiled to recover the balsam, the various tappings being combined to give a uniform quality product. To refine the raw material, (according to Retamar, 1986) the balsam was reportedly alcohol-treated, and the neutral solution of the resinoid in benzene then could be decolourised in part with activated charcoal, followed by extraction with freon 12 at 21°C. This method replaced the older method of heating over a fire to evaporate any remaining moisture and sieving whilst still hot, to remove organic matter. [You will note the former use of the carcinogen benzene in this process, quoted by Retamar as late as the year 1986].
…The balsam has been traditionally used for “warmth” and sweetness in perfume compositions, particularly as part of oriental themes. It also has significant uses in incense perfumes, being blended with musks, coumarin and animal notes.” Sensitisation to Peru Balsam exudates will often lead to complex multiple allergies, varying according to the individual (Hjorth 1959).
A Regulatory Screw-Up.
Crude Peru Balsam exudates have been listed in many trade publications as CAS No 8007-00-9, and are the subject of an SCCNFP Opinion (SCCNFP/0771/03), in consequence being added in the last Technical adaptation (Dir. 2005/42/EC) to Annex II of the Cosmetics Directive (76/768/EC).
For those needing a translation of all this legal jargonese, it effectively means that it was recommended that Crude Peru Balsam exudates cannot be used in fragrances because of their alleged skin sensitising potential.
Peru Balsam ‘Oil’ (generally encountered as ex- molecular distillation or very high vacuum distillation of the crude Peru Balsam, which offers yields of >50%), is identified under the same CAS No. 8007-00-9, and is the subject of an SCCP Opinion (SCCNFP/0392/00) which concludes that “Extracts and Distillates of Peru Balsam should not be used such that the total level exceeds 0.4% in cosmetic products.” [To any outsider it appears that the SCCP have merely rubber-stamped the previous IFRA Dec 1991 standard based on RIFM’s original work (including that of Opdyke (1974)].
Again the bottom line for those who need a simpler translation: It was recommended that Peru Balsam Oil was safe to use in fragrances at 0.4% maximum final concentration in the product.
The Confusion arises here because in the Technical adaptation (Dir. 2005/42/EC) to Annex II of the Cosmetics Directive (76/768/EC), in using the term CAS No 8007-00-9 as descriptor, it could be interpreted that both the banned (allegedly sensitising) Crude Exudate and the concentration restricted Peru Balsam oil (which is presumed safe at <0.4%) have been included in the Annex indiscriminately.
Memo to EU legislators: Crude Peru Balsam exudate needs to be separately identified (perhaps via a separate CAS No.) to distinguish it from Peru Balsam Oil, and the exact position clarified in Annex II above. Otherwise some might consider that the fragrance industry is placed in a legal ‘no man’s land’ over the legitimate use of Peru balsam oil. Already, as we write this (March 2006), fragrance companies fearful of being ‘caught out’ by this technicality are producing reconstituted synthetic versions of Peru Balsam Oil to substitute in their existing internal formulae which stipulate the ingredient.
The length of time it takes for the legislators to sort out these mistakes is quite unforgivable, bearing in mind the cost & inconvenience to industry, and the fact that Peru Balsam producers and traders face a period of uncertainty. As it is, expert committees/DG Enterprises are still scampering about trying to clarify the exact position (March 2006).
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Industry Loses Respect For EU Lawmakers.
The troubled Peru balsam saga took another turn for the worse this week. It seems that the ‘expert’ EC committees & advisors simply cannot get their heads around a concept which would not seriously trouble a beginner-trainee in perfumery.
Briefly, on the 1st April 2006, Commission Directive 2005/42/EC (20th June 2005) which amends EC Directive 76/768/EEC concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI to technical progress, came into force. Under Annex II (prohibited materials) now have we have under reference 1136:
1136. Peru balsam (INCI name: Myroxylon pereirae; CAS No 8007-00-9), when used as a fragrance ingredient.
DG Enterprises had previously asked the SCCP for clarification about whether the ban in the Opinion in SCC(NF)P/0771/03 applied to crude Peru balsam only, and whether extracts and distillates are safe under restriction set out in SCCNFP/0392/00 (i.e. IFRA’s previous restriction to 0.4% concentration max.).
The outcome is that Commission Working Document 06/COS/ENTR/05 presented at the December is believed to contain the following position, that the ban on Peru Balsam should only apply to:
Exudation of Myroxylon pereirae (Royle) Klotzch (Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient”.
Problems with this position. 1. It appears that the Chemical Abstracts Service is maintaining that CAS numbers are not assigned to exudates, as these are considered natural unprocessed materials. Cropwatch believes this news probably come as a bit of a shock to compilers of technical information to the natural products and vegetable drugs industry, which has used these numbers for decades. Cropwatch invites comments from companies & individuals who may be affected by this revelation. 2. It also appears that by including the CAS number bundled with the term ‘Exudation of Peru balsam’ (in spite of requests that the CAS number should be dropped), some parts of industry at least, are assuming that this will in fact be interpreted as Peru balsam oil (to which the term actually applies) in spite of EFFA’s pleas that the word should be spread that the ban will only apply to the crude exudates. We’ll have to see how this situation progresses, but already there are those that have lost patience with the whole situation and are substituting reconstituted Peru Balsam for Peru Balsam qualities in fragrance & flavour formulations. This situation hands another triumph to the synthetic chemical industry, and once more the EU Commission – for no good reason - puts pressure on what remains of the beleaguered natural products industry.
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Current Legal Status of Kava-kava in Wales.
Cropwatch wrote to the Food Standards Authority (FSA) on 7th April 2006 concerning the confusion over current legal status of Kava-kava in Wales, and within a fortnight received an informative reply from Phil Morgan, the Assistant Director FSA Wales. Cropwatch reproduces this reply here in the public interest.
“Thank you for your letter of 7th April….seeking clarification as to the current legal status in Wales of Kava-kava food & medicinal products.
May I first begin by explaining that the use of kava-kava for medicinal products is not permitted by virtue of the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002. These regulations were made using powers contained in the Medicines Act 1968. These functions have not been transferred to the National Assembly for Wales, and the above order therefore applies jointly to England & Wales.
In so far as foods containing Kava-kava are concerned, the powers to inhibit the sale & marketing of these products have been devolved. In response to concerns by the Independent Committee on Toxicology that Kava-kava posed a rare but serious risk to public health (due to an association with abnormal liver toxicology) controls on sales of food products were introduced across the UK in 2002 (including the Kava-kava in Food (Wales) Regulations 2002). Unfortunately after the Regulations had been made it came to light that there had been a technical flaw in the making process. On advice from Council, Assembly Ministers accepted the Regulations should be revoked and remade. Accordingly the Regulations were formerly revoked in late 2003. However the equivalent Regulations in the remainder of the UK were unaffected by this decision and therefore remain in force.
The making of fresh regulations in respect of Wales have since been delayed for a variety of reasons, but particularly to allow a review of the evidence base relating to the safety of Kava-kava Medicines & Food Regulations in England to be concluded. These parallel reviews, including consultations with stakeholders, took place in 2005. At broadly the same time, FSA Wales undertook a consultation involving mainly Welsh stakeholders on proposals to introduce fresh regulations prohibiting the sale and importation of Kava-kava for use in foods in Wales. This consultation was supported by draft Regulatory Appraisal outlining a range of policy options.
Although the consultation was completed some months ago – and incidentally no responses were forthcoming from stakeholders – no further action has been possible while the FSA/MHRA review processes were in progress. These processes, which included consideration by the relevant scientific advisory bodies of any available new data, have now been concluded. COT members concluded that the new data were not sufficient to demonstrate the safety of food products containing Kava-kava, particularly with regard to the severe nature of liver toxicity associated with Kava-kava consumption. The MHRA’s Expert Working Group concluded that on the basis of the available evidence the prohibition of Kava-kava in unlicensed medicines remains proportionate & justified.
FSA Wales will therefore shortly be advising Assembly Ministers of the outcome of the above reviews, and reporting the results of the consultation last year with stakeholders in Wales. Ministers will then be able to come to a considered view on re-introducing prohibitions on the sale of Kava-kava food products in Wales.
Finally I can ad to the best pf my knowledge there are currently no Kava-kava food products on direct retail sale in Wales.”
Click here to view the latest on the Peru Balsam Fiasco -
Public Consultation: Proposed Movement of Certain Perfumery Ingredients into Annex II/III of the Cosmetics Directive.
RIGHT OF REPLY TO SUPPORT THE PERU BALSAM INDUSTRY.
Jan 2007
References.
.Burfield T. (2005) from the forthcoming Natural Aromatic Materials – Odours and Origins [1st edn. pub. AIA Tampa (2001)].
Bjarnson B., Flosadottir E., Fischer (2000) "Assessment of Peru patch tests" Contact Derm. 42, 326-329
Forsbeck M., Skoog E. (1977) "Immediate reactions to patch tests with balsam of Peru" Contact Derm. 3, 201-205.
Hjorth, N. (1959) “Eczematous allergy to Balsam of Peru and allied natural resins.” Presentation to the European Congress of Allergy. London. Sept 3rd 1959.
D.L. Opdyke (1974), Fd. Cosmet. Toxicol. 12,951 and 12,953 and private communication to IFRA).
Retamar J.A. (1986) “Essential oils from Argentinian Aromatic trees, Shrubs and Herbs” in Ch3. ‘Essential oils from Aromatic Species’ in On Essential Oils ed. James Verghese pub. Synthite Kolenchery, India 1986 p 170.
Some Suggested Further reading:
Avalos-Peralta P., Garcia-Bravo B. & Camacho F.M. (2005) “Sensitivity to Myroxylon pereira resin (balsam of Peru). A study of 50 cases.” Contact Derm. 52(6), 304-6.
Hausen B.M. (2001) “Contact allergy to balsam of Peru. II. Patch test results in 102 patients with selected balsam of Peru constituents”. Am. J. Contact Derm. 12(2), 93-102.
Le Ciz CJ (2001) “Hypersensitivity to balsam of Peru (Myroxylon pereirae) Ann Dermatol Venereol 128(1), 71-2. (in French)
Katona M. & Egyud K. (2001) “Increased sensitivity to balsams and fragrances among our patients” Orv. Hetl. 142(9), 465-6.
Krob H.A., Fleischer A.B. Jr., D’Agostino R. Jr., Haverstock C.L. & Feldman S. (2004) “Prevalence and relevance of contact dermatitis allergens: a meta-analysis of 15 years of published T.R.U.E. data”. J. Am. Acad. Dermatol. 51(3), 349-53.
Pfutzner W., Thomas P., Niedermeister A., Pfeiffer C., Sander C., & Przybilla B. (2003) “Systemic contact dermatitis elicited by oral intake of Balsam of Peru” Acta Derm. Venerol. 83(4), 294-5.
Salam T.N. & Fowler J.F. “Balsam-realted systemic contact dermatitis” J. Am. Acad. 45(3) 470-2.
Schnuch A., Lessman H., Geier J., Frosch P.J., Uter W.; IVDK. (2004) “Contact Allergy to Fragrances: frequencies of sensitisation from 1996 to 2002. Results of the IVDK.” Contact Derm. 50(2), 65-76.
Tanaka S., Matsumoto Y., Dlova N., Ostlere L.S., Goldsmith P.C., Rycroft R.J., Basketter D.A., White I.R., Banjeree P., McFadden J.P. (2004) “Immediate contact reactions to fragrance mix constituents and Myroxylon pereirae resin.” Contact Derm. 51(1), 20-1.
Trattner A., David M. (2003) “Patch testing with fine fragrances: comparision with fragrance mix, balsam of Peru and a fragrance series” Contact Derm. 49(6), 287-9.