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March 08, 2008

Furanocoumarins in cosmetics – worrying developments

IFRA IL 799. 

UPDATED to correct abbreviation error.

IFRA have just released an Information Letter (IL 799) on 'Controlling furanocoumarins in citrus & other essential oils', together with a document on FC's in cosmetic products. Ordinary members of the public, and citrus oil end-users who are not members of the requisite professional trade associations, may find this IFRA Information Letter difficult to locate, but essentially the letter notes the following: 

  1. That a previous IFRA Standard limits FC's (specifically bergapten) to 15ppm in consumer products for UV-exposed skin.  Cropwatch comments: As far as we can establish, few perfumery companies have ever abided by this IFRA Standard, and a considerable number of individual working perfumers who we have previously contacted remained completely uneducated about FC levels in the aromatic ingredients with which they construct perfume formulae.  Little information either has been publicly available from any citrus product supplier. A recent suggestion by the Cosmetics Regulator (in a communication to EFFA) that FC's in aromatic ingredients can be estimated by HPLC, shows how removed these officials are from any economic & practical reality, and how they continue to only be able to suggest high-technology fixes which economically discriminate against the economic resources of smaller companies. 
  2. Entry 358 of Annex II of the Cosmetics Directive prohibits FC's in cosmetics except for any natural presence in essential oils. In sun-protection & bronzing products FC's are limited to 1 ppm. Cropwatch comments: Again there is little evidence that there is any awareness of the universal enactment of this legislation within the EU marketplace.   
  3. The SCCNFP Opinion SCCNFP/0392/00 September 25th, 2001 called for a limit of 1ppm of total "furano-coumarins & furano-coumarin like substances" in finished cosmetic products, an imposition which was fifteen times more severe as the existing (& probably little-adhered to) IFRA Standard mentioned above. Cropwatch comments: The SCCP Opinion on Furanocoumarins in Cosmetic Products (SCCP/0942/05), ratified on the 13th Dec 2005 is more recent. As usual, the SCCNFP's/SCCP's spoon-fed comprehension of the ingredient toxicology in both instances was incomplete, and its "experts" did not fully appreciate that not all FC's & "furano-coumarin like substances" necessarily present a photo-carcinogenic risk; indeed some might show photo-protective properties. The Opinion was therefore contemptuously received, as well as being practically unworkable in the absence of clear data showing FC concentrations across the huge range of FC-containing aromatic ingredients in the perfumer’s palette. Not the least, the imposition of such a severe limit for FC's in finished cosmetic products would practically eliminate the use of citrus oils in fragrances, as Cropwatch has previously extensively discussed in its Newsletters over 2006-2007. 
  4. According to IL 799, "the industry" (individual company identities withheld), the industry-funded RIFM organisation and the EU Commission have reportedly embarked on a collaboration which has resulted in a Risk Assessment which "was shared with the European Commission at the end of 2007" (public accessibility of this Risk Assessment is unstated). Reportedly, this proposes that for leave-on products, a limit of up to 5 ppm FC's from a combination of any of the 6 following FC markers will be allowed: bergapten, bergamottin, byacanangelicol, epoxy-bergamottin, isopimpinellin & oxypeucedanin. A less restrictive limit of 50 ppm of FC's  for rinse-off products is also proposed. IFRA have suggested that "the Industry", for whom it increasingly seems to be the self-appointed spokesperson, meets DG-Enterprise/DG-Sanco "to explain & discuss its proposals in more detail". Cropwatch comments. The specter of a few un-named megacorporations which are potentially able to finance safety research and thus to dictate areas of EU safety policy is alarming, especially as complex bureaucracy such as that in the above scheme, will advantage the larger aroma concerns, and discriminate against the smaller companies - a worrisome area which could so easily become considered as falling into a restrictive practice.

CONCLUSIONS 

Cropwatch maintains that, as we said before, the case against the photo-toxicity of individual FC’s, as presented in previous SCCP Opinions such as SCCP 09542/05, remains scientifically non-robust, and there is a lack of supporting knowledge, understanding & experimental & technical data. For FC’s occurring in natural aromatic products, matrix effects & the anti-carcinogenic potential of other co-occurring substances remain unclear. Whether any newly presented evidence will instantly clarify this position is uncertain, because although we are supposed to live in a European democracy and there is supposed to transparency in all EU Commission safety policy dealings, key documents relating to safety studies in this area continue to be withheld from the general European public.   

Cropwatch suggests the following to its supporters: 

  1. The proposed legislatory conspiracy between unidentified industry concerns, IFRA-RIFM and the EU Commission, to limit FC levels in finished cosmetics for sale in the EU marketplace, is vetoed by the cosmetics & natural products trade in general. This is because the EU Cosmetics regulatory officials have so far failed to clearly & unequivocally establish a robust case of need to control the existing levels of consumer exposure to FC's in cosmetics. 
  2. That the lack of transparency in the evidence-submission process surrounding alleged FC toxicity/carcinogenicity data is corrected by EU officials & advisors. This sort of secrecy is not acceptable in a supposedly democratic European society.

It should also be noted that the outfall from the suggested Risk Assessment allegedly submitted by IFRA/RIFM to the EU Commission for its consideration in late 2007, is likely to do little to address the problems of the continued freedom to use certain citrus ingredients in perfumery/natural perfumery. We all know in our heart-of-hearts that the more the larger Aroma Corporations fund the activities of regulatory-centered bodies such as RIFM, IFRA, EFFA etc., the quicker the end will come for unrestricted natural ingredient usage in perfumery.    

Tony Burfield
Cropwatch.

Posted by Tony Burfield on March 8, 2008 in Perfumery, Regulatory Issues, Safety/Toxicity | Permalink

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