The Peru Balsam Fiasco.
Revised & Updated
Copyright Ó Cropwatch Sept.2005 - April 2006
Skip to Update April 2006
Skip to Further Update
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).
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.
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.
.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.
Veien N.K., Hattel T., Laurberg G. (1996) "Can oral challenge with balsam of Peru predict possible benefit from a low-balsam diet?" Am J. Contact Derm. 7, 84-87.
Veien N.K., Hattel T., Justesen O., Norholm A (1985) "Oral challenge with balsam of Peru" Contact Derm. 12, 104-107.
Veien N.K., Hattel T., Justesen O., Norholm A (1983) "Oral challenge with balsam of Peru in patients with eczema: a preliminary study" Contact Derm. 9, 75-76.
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.