Another TPD Implementation

As the date draws closer for actual implementation of the voted-in Tobacco Products Directive, EU Member States are producing their interpretation of the Directive. Unlike the UK which has been decidedly light-touch, though how light-touch remains to be seen, Member States have taken to adding a bit extra – i.e. “Gold Plating” the Directive which only serves to make it worse. Belgium are going to be charging 4,000 Euro per notification which is a disastrous amount for smaller businesses to bear. Finland is being downright stupid and now we have Hungary.

It starts to go wrong almost immediately in the draft document where the Hungarian Government define nicotine containing liquid (emphasis mine):

nicotine-containing liquid: liquid utilised in the course of using electronic cigarettes or for refilling them that contain any amount of nicotine, however small.’

Hungary have decided that their ‘competent authority’ (as per the Directive) is to be the National Institute of Pharmacy and Nutrition. Notifications must therefore include the following:

  • Name & Contact details of the manufacturer and the importer
  • List of all product ingredients and emissions created when using the product, and their respective quantities, by brand name and type
  • Toxicological data on product ingredients and emissions, primarily on their impact on consumers and users exerted through inhalation, taking into account any impacts potentially causing addiction
  • Information on the product’s valid nicotine dose and absorption when used for its intended purpose or under conditions which can reasonably be foreseen
  • A description of product components, including the mechanism of the electronic cigarette and of the opening and refilling of the refill container
  • A description of the manufacturing process, including whether the product is serially manufactured, and a declaration on whether the manufacturing process ensures compliance with legislative measures
  • A declaration that the manufacturer and the importer assume full responsibility for the product’s quality and safety in the context of its placement on the market and use for its intended purpose or under conditions which can reasonably be foreseen

That’s just to notify to place a product on the market. How the EU ever thought that this Directive would “harmonise the internal market” is beyond me, every Member State is using different rules within the scope of the Directive. Fortunately, in this case there doesn’t appear to be a cost associated with the notification process, at least it isn’t mentioned in the Decree Amendment.

Next we come to the part of the Amendment that is effectively the death knell for vaping in Hungary.

TPD

In short, “electronic smoking imitation devices” may be placed on sale in Hungary as long as:

  • The  liquid doesn’t contain nicotine
  • Doesn’t contain flavourings
  • Doesn’t contain any of the specified additives
  • Doesn’t contain any vitamins or other additives that give the impression the product has a beneficial physiological impact or is less harmful to health
  • Doesn’t contain any of the listed stimulants
  • Doesn’t contain any colourings
  • Doesn’t contain additives with CMR properties (taken straight from the Directive section on tobacco)
  • May not contain ingredients with more than 0.1% impurities – though it doesn’t specify what that percentage relates to, most likely the volume of the added ingredient
  • May only contain ingredients that are not harmful to human health, heated or not – that narrows the list considerably
  • To be fitted with a child safety lock system – fuck knows how this is going to work, is this a second button for firing? some kind of cover? again, no specifications are present, as with the overall “leak free filling” aspect of the Directive itself.
  • To be protected against breakage and leakage – so break and leak-proof – and be fitted with a leak free filling mechanism

So Belgium puts a ridiculous cost for notification, while Hungary decides you can have no-nic, unflavoured liquids as long as this list of additives aren’t present, oh and this list of stimulants aren’t in there. By the way, you can’t have these additives either, nor can you use that if it has more than 0.1% impurities.

Talk about taking all the fun out of vaping.

But there’s more.

Leaflets to be provided specifying the elements listed in 19/B(2) (which isn’t in the draft amendment) to be added to the unit packets – so just like the useless warning leaflet I throw away whenever I open a pack of Ibuprofen.

Standardised packaging (already) to include product ingredients (listed in descending order by weight), manufacturer batch number and of course the “Keep out of reach of children” warning. Fortunately there aren’t any specifics on how big that warning has to be, though it is likely to be “Directive size”.

Packaging to comply with the requirements as defined in the Act on the Protection of Non-Smokers (of course). Along with health warnings, and last but by no means least, covering at least 30% of both sides is to be the following:

This product is an electronic smoking imitation device. Not recommended for children

Hungary haven’t just gold-plated the Directive, they’ve decided to go a step further with some gold-pressed latinum.

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