There has been an increasing amount of confusion about how nicotine solutions destined for e-cigarettes should be classified under CLP (Classification, Labeling and Packaging of substances and mixtures). Not only has there been noticeable discrepancy between advice given by the regulators in different EU countries, but also from other sources as well.
Therefore the people at ECITA (Electronic Cigarette Industry Trade Association) asked for help the experts from bibra (a UK toxicology advice & consulting company)who calculated that, based on the data in the CLP regulation, the acute oral and dermal toxicity of nicotine solutions of less than 2.5% are not classified under CLP, and that solutions of 2.5 to 5% are classified as category 4 (the lowest).
These results came as a surprise for ECITA, given the scale of exaggeration in today’s media, despite the fact that they already knew that some of the info was not based on studies but rather on personal fears and prejudices.
After seeing this results, the people at ECITA decided to ask for a second opinion and sent the info to some esteemed scientist across the continent. Professor Bernd Mayer, Professor & Chairman of the Department of Pharmacology and Toxicology at Karl-Franzens-University, Graz responded:
‘In his report, Peter Watts discusses the LD50 values of nicotine reported for different species. For the calculation of ATE [Acute Toxicity Estimate] he uses the widely accepted oral LD50 for rats (50 mg/kg). Taking the rat LD50 is generally accepted even at courts and every toxicologist will follow this rule. So Peter Watts’ calculation is definitively correct.’
Professor Riccardo Polosa, Full Professor of Internal Medicine at the University of Catania responded:
‘After careful cross-checking of the calculations and verification of the ensuing reclassification, it is clear that the approach, calculations and reclassifications given in the bibra Proposal are correct.’
Dr Jacques Le Houezec, an Independent Consultant in Public Health and Tobacco Dependence said: ‘The bibra report presents the calculations based on different dilutions, including those used for e-liquids. It clearly shows that the current CPL regulation is not following the principles of EC Regulation 1272/2008. The consequence is that all e-liquids with a concentration of less than 2.5% (25 mg/ml) should not be classified under the EC regulation [for acute oral or dermal toxicity], and that higher nicotine concentrations (up to 5% or 50 mg/ml for dermal classification, and even higher for oral classification) should be considered as CPL category 4’.
However, even though the toxicity of e-liquid is not as high as most people would expect, ECITA wants that its members should respect some guidelines when selling the bottles. Therefore they have come up with some guidelines, essential for any e-juice sold in the EU. Besides the child-resistant caps that must be used on all types of bottles destined for e-liquid,
E-liquid labeling must include, as a minimum:
- the heading: ‘CAUTION:’
- the text: ‘Store locked up and out of the reach of children and pets’
- Nicotine concentration in weight per volume (w/v) percentage and/or milligrams per milliliter (mg/ml) must be marked on the label
- The text: ‘Only for use in electronic cigarettes’
- The text: ‘Seek medical advice if you feel unwell’
- Contact details must be displayed
- All of these label elements must be visible, legible and indelible