Tobacco Documents Online

S /PSS/ D-9 1Oth February0 1977 DIETHYLENE GLYCOL An appraisal of the use of this material in tobacco products has already heensu~aittedh~Gallaher. The appraisal led to the rec~ation that ~ethylene glycol should not be used for humectant purposes. This recommendation should he accepted. Nevertheless it is considered that there is a case for permitting the use oE DEG at low levels. The purpose of this exempti~ is toper m it the use of DEG as a minor carrier solvent for certain flavour c~ponents. In commercial practice it is found that, since DEG is permitted In Europe, many European flavouzhousesprepare flavour concentrates in this molvent and are generally not prepared to produce all such concentrates in an alternative carrier solvent when the volume required is small. However, we have been assured on a number of occasions that should sales reach an appreciable level the flavourwouldbe supplied in a more acceptable carrier solvent. As the attached notes indicate it is believed that it would,be perfectly feaslble and of practical importance to accept the use of low levels of DEG. O CD cr~ CO

-2- AN ASSESSMENT OF THE USE OF LOW LEVELS OF .D.E.G~. To be read in conjunction with the appraisal submitted bF Gallaher. Prior to more detailed consideration of appropriate levels, it is probably worth emphasislng the following points: [a] DEG has a long history of use in tobacco products and is widely used in Europe being a permitted humectant in Germany. (b) Much of the early toxicity data is suspect because the level of monomer was not speclfled. (c) As indicated in the Gallaher appraisal, the BIBRA study showed that a dietary level of 0.085% DEG was without detectable effect in the rat. Additionally, it was concluded that a no-untoward effect level of O.17% would be unlikely to increase the normal oxalate exaretion in man. The latter figure is equivalent to a daily intake of approximately 50 mg DEG for a 50 kg individual with the usual foe-fold safety factor. e3.S. Of use I CSq rettes ....... -Under-st andard- condltl ons ;--the-T~ ~sTer of .............. DEG i 14% maximum transfer Is 20~ heavy smoker smokes 50 clgs/day o O cr~ co tJ~

-3- II Hence maximum DEG on cigarette tobacco" "- • o mg DF~3 X ~ X ~O mg DEG per clga=ette 50 - 5 mg per cigarette i.e, O.5~ D~ on ciqarqttes Pi~ Tobacco~ .Under standard ccmditions, the transfer of DEG = 50% Assume (1) maxtn~mtransfer iS 70~ [2) heavy smoke: smokes 5Og/day 50 mg x ~ x ~O par g pipe tobacco - 1.4 :g/g i.e. ~ O.15~ by weight SDecificatio~ It is ccmsidered that tt would be prudent to =estzict the maximum level of monomer in diethFlene glycol used. Good quality DEG contains less than O.1% monoethylene glycol and this level would appear to be satisfactory, a 16 week study in the rat has been completed bF BXBRA (Research Report No. 4/1974). P~omm~ndatlons (1) The use o£ diethylene glycol sh~ldbepermitted but limited to a maximum of and O.5%DEG on cigarettes O.15% DEG on pipe tobacco. O O PxJ (30 O~

t -4- (2) The diethylene glycol used should not ~ontain more than 0.1% monoethylene glycol. o o o~ c~ aD ~j