Clive Bates | 20 December 2013
- Maximum nicotine density for e-liquids now at 20mg/ml. Completely counterproductive – limiting e-cig appeal to heavier smokers, preventing more compact energy efficient devices, and blocking future innovations. And cuts through the ranges of the major manufacturers. But significantly lower thresholds were under discussion at one point – the Germans wanted 5mg/ml!
- Maximum nicotine quantity per single use cartridge - at one point an unfeasible 10mg – now specified as 2ml (therefore up to 40mg if the liquid is 20mg/ml) in a single use cartridge. There was no need to limit this quantity at all as safety concerns are addressed through packaging standards.
- Maximum refillable container size of 10ml has been agreed. Stupid and pointless, but not fatal as I think quite a common refill size. We would normally control risks from hazardous liquids by packaging and labelling – not by reducing the size. Imagine if we took that approach to bleach or drain cleaner.
- No EU ban on refillable (2nd and 3rd generation) devices . This was in prospect but has been successfully thwarted – though with some strings. The Commission will have powers to ban them if three members states do and they can justify it on proportionality grounds – though this is more likely to apply to a specific dodgy product than the entire refillable category.
- No EU flavour bans. Regulations are to be left to the members states. At one point they wanted to allow only flavours approved for use in NRT, which would have been absurdly limiting. But now we will probably end up with lots of arbitrary rules based on the wrong assumption that adolescents want to use flavours that are childish. I reckon if there was anthrax flavour it would be more popular with them than strawberry sherbet or. whatever…
- Many forms of advertising, sponsorship, promotion, product placement – TV, radio, cross-border – are banned. This is ridiculous and disproportionate – and will cause all sorts of damage (eg. to sponsored forums). The products are much less dangerous than alcohol and could be regulated with a code - as the UK is planning to do .
- Cross border distance sales - these can be banned by member states, but are not automatically banned.
- Lots of testing, reporting and compliance requirements - but no pre-market authorisation regime, which would have created major political and administrative barriers
- Age limits. Not included as these are a matter for member states.
- Medicines regulation - they seem to want the flexibility to regulate e-cigs as medicines at national level. Heads in the sand on this, given they keep losing in court.
- Timing . Looks like intent is to bring in the measures 24 months after entry into force (likely May 2016) with possible additional 12 months for non-compliant products already on the market – this is one area that is unclear in the drafting.
- A number a strange statements are made in the recitals to justify the measures, for example about a gateway effect – something there is no evidence for at all.
- At every opportunity write to MPs, MEPs and ministers and keep making the case relentlessly. Watch forums for tactical advice on when and who to contact and on what theme.
- Consider political strategy for the directive - come out fighting or move with the punch…?
Come out fighting? Should we try to get this rejected at the European Parliament plenary? One approach would be a simple ‘delete’ amendment, replace with “The Commission shall consult and publish a review the risks, benefits and regulatory arrangements for e-cigarettes within 12 months and bring forward legislative proposals as appropriate”. The value of this depends on the prospect of securing a majority in the European Parliament – that is still hard to gauge at present. It would be necessary to show some fairly blatant unintended consequences or harms to convince MEPs to go out on a limb for this.
Move with the punch? Focus on making the implementation work and pressing for flexibility where there are obviously errors. Working out what it means in practice and focussing on implementing regulations. We would need some key flash points to tackle with this.
- Recognise that product regulation is one battle of many. There is still huge work to be done on many fronts: vaping in public places: the attitude of NHS, Directors of Public Health and local authorities; keeping the MHRA in its box; and generally winning a propaganda war in which supposedly respectable organisations are playing dirty and elements of the media are taking every opportunity to have a go.