It is claimed that Bismarck once said that you should never allow the public to see how sausages or laws are made. The negotiations between MEPs and EU government representatives that took place last night could have proved his point.
A messy process has ended up with confusion on all sides, stemming partly because there was no chance to study the final text in detail (it was still being tidied up this morning) or to assess its implications.
The situation is a bit clearer now, although the deal has still to be ratified by the EU governments collectively. I wanted to write to you to and set out what the legislation does say – and more importantly what it doesn’t.
Remember that we started off with the European Commission insisting that e-cigs should be classified as pharmaceuticals, and subject to expensive approval procedures and a host of regulations and restrictions in different countries.
Almost all governments backed this stance.
So although the European Parliament voted for a different approach MEPs have had an uphill battle to get their wishes accepted.
The deal negotiated between the Parliament and the Council of Ministers is not perfect (they never are). I would have preferred to see less regulation on concentrations and volumes, but when compared to the initial proposals I think our negotiating team have done a fantastic job.
Below is a list of facts about the legislation and a bit of explanation about why it is written as it is. I’ve read the actual text of the proposal and I know that a lot of the speculation on the internet at the moment is wrong!
Please drop me an email at firstname.lastname@example.org if you have any questions and I will do my best to answer them.
Chris Davies MEP
Liberal Democrat environment and health spokesman
Refillable tanks and the two year report
The legislation requires the European Commission to report back in two years on the safety of refillable cartridges. That doesn’t mean they are being phased out after two years, it means there will be a discussion. It will give time for manufacturers to demonstrate the safety of their products.
More information on safety is better than less and vapers will want to know if the products they use are safe or not.
Banning certain products
A lot of people have claimed that if three countries ban refillable cartridges they will be banned everywhere. This is not true.
If three countries can prove that there is a safety risk with a particular type or brand or cartridge then the European Commission can adopt measures to ban it. BUT, this will only apply to the specific product, not to all of them, AND the European Parliament has the right to veto any such ban.
There will be a ban on liquids containing a higher concentration of nicotine than 20mg/ml and a ban on having more than 2ml of liquid in an e-cig. That means there will be a maximum of 40mg (20mg/ml x 2 ml) in any one e-cig.
There will also be a limit of 10ml liquid in any one refill bottle but no limit on the number of bottles you can buy.
There are no regulations as to flow rate through an e-cig. (Some studies have shown that the concentration of nicotine in a puff is dependent more on the e-cigarette than the liquid concentration).
These are safety measures. A spoonful of concentrated nicotine could kill a child and restrictions of some kind were inevitable. The original proposal was for a restriction of 4mg/ml and no refillable cartridges so this is a far better deal than we could have expected. It might mean people have to refill more often or take longer puffs but it won’t have any impact on the amount of nicotine you can physically breathe in.
Cartridges and refill bottles will need to be childproof and not leak during refilling. I don’t know of anyone who thinks we should put nicotine liquid in a form that would let kids accidentally ingest it.
These will be regulated at the level of individual countries but, importantly, no country will be able to ban a flavour that is allowed in another country and cross border sales will be allowed. One of the advantages of the European Single Market is that if you can’t buy it in the UK the Swedes or someone else may sell it to you!
E-cig manufacturers will have to let governments know within six months what ingredients are in their liquids. They will have to include leaflets and labels including health warnings that nicotine is bad for you and that e-cigs aren’t for the use of non smokers.
Advertising will also be severely restricted.
A manufacturer will be able to apply for medicinal approval if they want to make health claims about their products, but in general the EU will not classify e-cigs as medicines.
It is still possible for any government to insist that e-cigs should be classified as pharmaceutical products in their own country. The same legislation can apply to ANY product, but there might be legal grounds for challenging it if applied to e-cigs. But the new EU rules provide an alternative legal framework for controlling e-cigs so fewer governments are likely to take the pharmaceutical route. Anyway, the decision will be taken in London not in Brussels.
And then there is always the internet!