July 29, 2009
Notes and News
Those involved in natural cosmetics and the manufacture of aromatherapy products in the United States are not always aware of what’s percolating in regulatory circles across the pond. There is a searchable database, COSING, established by the EU, which is extremely helpful to quickly find pertinent information. These regs may or may not appear in our own rules here at home as the FDA continues to masticate on the globalization act of 2008. Of the greatest interest, rules regarding the 26 fragrance allergens now required to be labeled on cosmetic packaging if in products above 10 ppm in leave-on products, or 100-ppm in wash-off products. Perhaps 50% of these allergens are found naturally in limonene, citronellal and linalool . . . all which occur in essential oils. In this directive, fragrance allergens are considered regardless if they come from essential oils or synthetic manufacture.
We owe great thanks to Tony Burfield for his diligence over the past two years to provide information here on aromaconnection about EU directives, IFRA and other regulatory issues.
The volunteers at aromaconnection have all been very busy with other aspects of their lives for a bit of time, however, we hope to be back stronger than ever by the fall.
July 18, 2009
Robertet Reveals its Evidence on Melissa Oil to Cropwatch
by Tony Burfield July 2009
You may remember that Cropwatch was quite puzzled by any need for IFRA’s new restrictive Standard for Melissa oil in IFRA’s 44th Amendment, and had requested details of three unpublished toxicology reports from both RIFM & Robertet, Grasse, which were not available in the public domain, but which were cited by IFRA as containing evidence sufficient to restrict its use in perfumery. The back-story on this matter is available in the Cropwatch Files at http://www.cropwatch.org/Meliissa officinalis - Cropwatch article archive.pdf, but to briefly recap, although Melissa oil & extracts occupy an important place in aromatherapy and herbal medicine, Melissa oil is virtually unused in corporate perfumery. Nevertheless IFRA had previously seen fit to ban it as an ingredient on the basis of undisclosed evidence. There seemed to be no such body of evidence within the RIFM data-base to support such a ban, and it is a complete mystery to many of us how REXPAN could have come to such a conclusion. The ban has now been transformed into a concentration restriction under IFRA’s hyper-bureaucratic QRA system. In the interests of Freedom of Information, Cropwatch has compiled a comprehensive bibliography of the available literature on Melissa oil in the Cropwatch Files section of its website, to enable any interested parties amongst the general public at large to make their own minds up about the need for any restriction.
Although RIFM has ignored Cropwatch’s request for the withheld evidence on Melissa oil as noted above, Catherine Gadras of Robertet, Grasse very kindly responded with a summary of the test data, which is displayed at http://www.cropwatch.org/Melissa EO testing summery.pdf, and offered to answer any further points. Accordingly we asked Robertet (on 14th June) to accurately define the botanical nomenclature of the Melissa species employed (was it, for example, the oil from Melissa officinalis L. subsp. officinalis?), the geographical origin of the Melissa herbage used to steam distill the essential oil, and the compositions of the oils employed in the research (since commercial Melissa oils vary widely – see Cropwatch’s Melissa oil bibliography). We also asked, in as many words, if the Robertet team would like venture any comments on the fact that there was a complete lack of adverse human reactions in the Robertet HRIPT studies, contrary to the numerical indications of possible sensitiser activity shown by the EC3 value? Without going into too many further details, this data would seem to offer further support as to the flawed ability of the LLNA test to accurately predict sensitiser potency for aromatic ingredients, and its questionable place of this animal-based test within the over-bureaucratic QRA system. But presumably, unless a notable such as Professor Axel Schnuch stands up and gives a paper on perfume ingredients with indicatory EC3 values which do not produce a significant number of adverse reactions per 10,000 dermatitis patients, no action will be taken by IFRA or by the `EU’s ‘expert’ committees to scrap this flawed QRA system (we make this comment since Schnuch’s evidence seems to have contributed to the pressure on the EU Cosmetics Commission to belatedly review the situation regarding notorious 26 Allergens debacle - see Cropwatch Files).
If we receive a further reply from Robertet regarding further details of the toxicological studies on Melissa oil, we will post it in the public interest. We should point out that in asking these questions, we did not mean to place Robertet in an awkward position (Robertet being a Direct Company Member of IFRA). However as Martin Watt noted when presented with the Robertet studies summary recently: “(the data presented)… is all typical in-house testing and certainly NOT suitable for ANY scientific evaluation purposes.” And further: “My key point is that RIFM data is only trade recommendations. The EU committee is attempting to turn those 'recommendations' into EU law. So far without success, but they keep trying. Only publicly discrediting that committee and the administrators in the European court will anything change.”
Cropwatch’s feeling is that the IFRA/RIFM/REXPAN conglomerate is struggling: better toxicological facilities & superior expertise in specialized subject areas are available outside the organisation, and this situation together with the fact that people are better informed on toxicological matters is stretching the credibility of many of IFRA’s policies and its decision-making generally. The perfume industry certainly needs a safety organisation to protect its interests – but maybe not this one, which is guilty of over-regulating the industry, and confuses the career interests of its composite toxicologists over and above its function to be a balanced safety policy-making unit for the trade.