Implications of product testing: method variability and suitability and ratio of smoke emissions to nicotine
Regulatory authorities are discussing the measurement of certain smoke constituents, and this may eventually lead to discussion of ceilings. For this purpose internationally standardised methods are required to enable the generation of reliable data. CORESTA has strongly supported the development of robust methods to deliver information on method variability based on sound science. This information will enable regulatory authorities to take method variability into account when considering setting ceilings for smoke constituents.
To date, CORESTA has published six recommended methods encompassing 25 compounds. Four of these methods have already been submitted to ISO as potential ISO standards. This process includes a series of collaborative studies involving a number of laboratories to assess the reproducibility and repeatability (R and r) of each method.
All studies conducted were statistically designed to investigate effects of parameters that could contribute to within-lab and between-lab variability. As a result, the method variability is recorded in the published recommended methods. Overall reproducibility data shows a significantly higher variability compared to the analytical methods for tar, nicotine and carbon monoxide currently applied by authorities for measurement and ceilings in the EU. This fact should be considered in case ceilings for further smoke analytes are proposed.
Additionally, WHO TobReg has proposed nine priority compounds for regulation and recommends reporting levels for smoke compounds in terms of per milligram of nicotine. In TobReg’s view the sale or import of cigarette brands that have yields above these levels should be prohibited. An unintended consequence of the introduction of independent multiple analyte ceilings based on a ratio to nicotine would be to prohibit the sale of many products with low smoke constituent yields within a given market with the result that the average smoke constituent yields in the market would rise.