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April 28, 2008
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
Posted by Tony Burfield on April 28, 2008 in Aromatherapy, Essential Oils/Plant Extractions, Perfumery, Regulatory Issues, Safety/Toxicity | Permalink
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