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February 28, 2007

Ethanol Risk (?)

An interesting situation blew up regarding ethanol toxicity for the EU cosmetic regulators, where seemingly the imposition of their own health & safety policies could have threatened the stability of the very industry they were regulating. Of course the regulators could contrive to bend the rules – but if they did bend them for ethanol, then why not also bend them for other important natural products that have inconvenient toxicological properties?

The development of high-art perfumery in Europe is of course linked to the use of aqueous ethanol (alcohol), where it acts as both a solvent and reactant for the constituent ingredients i.e. in a sense, the odour profile of a matured ethanolic fragrance can be considered greater than the sum of its individual odourants as a number of chemical changes and equilibria are set up over a short period between reactants and their stable/quasi-stable products. The addition of aqueous alcohol to ‘perfume compounds’ (the term for a perfume formulation minus the ethanol or other carrier) is a therefore a process which traditionally has required a little ‘know-how’ to obtain optimal results.

The preparation of natural aromatic ingredients (such as absolutes, tinctures & ingredient dilutions) is also linked to ethanol use. Whereas modern methods of preparation of absolutes invariably gives ingredients with very low percentages of residual ethanol, the use of tinctures (ethanol extracted/matured solutions of aromatic raw materials) would be more directly affected. However moderate corporate perfumery rarely incorporates the use of tinctures nowadays – it is part of a lost art – but this is not necessarily so in natural perfumery.

The French independent occupational safety group, the National Institut de Recherche et de Securite, had submitted a proposal in 2006 (their motivation is unknown to me) to classify ethanol as a category 1 CMR (Carcinogenic, Mutagenic or Reproductive toxin - see EC Directive 67/548) substance under EC Directive 67/548/EEC – a Directive which relates to the classification, packaging and labeling of dangerous substances. Up to that point, and under the 7th Amendment to the Cosmetics Act 76/768/EEC, if successful this categorization move would have required the European Commission to ban ethanol in cosmetics (and therefore perfumery). Additionally the European Chemicals Bureau had on its agenda for Oct 7th, a proposal to classify ethanol as a CMR material:

COLIPA had also submitted an opinion pointing out the socio-economic implications of this ban, which would require the banning of perfumes, after-shaves, colognes, eau de toilettes, some mouthwashes etc etc. and points out that this move if enacted would require many workers to wear gloves & respirators to avoid contact with ethanol i.e. when working in bakeries (ethanol is produced by panary fermentation in bread dough), in hospital labs, in bars etc. etc.

EFFA had argued that effective risk management is already in place for ethanol and only direct oral consumption is linked to adverse health effects – therefore EFFA's reasoning is that objections under the labeling directive 67/548/EEC do not address the problem (i.e. the problem is seen as purely that of oral intake).

Nevertheless up to that point, under the proposed classification for ethanol under National Institut de Recherche et de Securite proposals would seem to be:

F (R11: highly flammable) - this is unchanged, but additionally:

T Mutagenic Cat 2 (R46: May cause heritable genetic damage)
T Carcinogenic Cat 1 or 2 (R45: May cause cancer)
T Reproductive Toxin Cat 1 (R60: May impair fertility)
T Reproductive Toxin Cat 1 (R61: May cause harm to the unborn child)
R64: May cause harm to breast-fed babies

So the proposed labeling would be:

Symbols T; Xi; F
The Risk Phrases would be R11-R36/37-R40-R46-R60/61/64
The Safety Phrases would be S1/2-S26-S45-S46-S53.

However more careful examination of the ECB website under meeting schedules 4-5th October in Arona, reveals that there is a section for documents under 5.2 ‘Classification of Existing substances not subject to Risk Assessment’, where we see the  entry for MOO5 Ethanol.  – “No in depth discussion foreseen on mutagenicity and reproductive toxicity”. So does the philosophy of the 3 Wise Monkeys (hear no evil, see no evil, speak no evil) apply here – if so don’t open the huge & horrendous  MSDS data file for ethanol ECBI/22/06 in the next column.

The update document  ECBI/22/06 Add. 1 by Jan Cepcek of the Centre for Chemical Substances & Preparations in the Slovak Republic might have the last word here, where Cepcek argues that it is appropriate to separate industrial ethanol from ethanol in alcoholic beverages. Which neatly hands the problem conveniently on, as one strictly pertaining to food safety.

So, a return of the days of prohibition, perhaps? Knowing the influence of big industry on the EU regulatory process, I very much doubt it….!

Tony Burfield

Posted by Tony Burfield on February 28, 2007 in Regulatory Issues | Permalink

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