TPD2 Review - Xyfil

The UK Government recently created a public consultation with regards to the implementation of the Tobacco Products Directive (TPD). As an e-liquid manufacturer, the TPD implementation is something of high importance to us to ensure that the legislation is a win for the consumer – you can read our responses to the consultation here.

If you wish to read the highlights of the consultation outcomes, here is our summary:

  • The Government received a total of 709 responses, of which 56 (7.9%) were from e-cigarette stakeholders
  • The Government clarifies that some stakeholders incorrectly assumed that proposals aimed solely at tobacco products also apply to e-cigarettes. Thus, only article 20 of the EU-TPD2 applies to the e-cigarette industry, along with articles that confer powers to the regulatory authorities, define offences, consequences of committing offences, etc.
  • Non-nicotine or zero nicotine e-liquids are excluded from the scope of TPD2. This exclusion will not be recognised in Scotland with respect to age restricted sales. Please note that the implications of this do not extend to hardware supplied with zero nicotine e-liquids as the directive clearly includes ‘any device that can be used for the consumption of nicotine’ in its stipulations
  • Businesses established outside of the UK and engaged in cross-border sales of tobacco or e-cigarettes will require registration and to nominate a responsible individual in the UK to help ensure products sold into the UK conform to the UK law and will assist enforcement authorities with compliance such as consumer complaints, product recalls and withdrawals. The Government clarified that the supplies or retailers selling e-cigarettes are also included in the definition of producer
  • The Government will set up and maintain a register of registered businesses engaged in cross-border distance sales (as well as those operating in the devolved administrations of UK) of e-cigarettes and refill containers. In England, at this stage, there will be no registration scheme for domestic sales
  • Businesses selling e-cigarette products online (i.e. distance sales) will have to demonstrate an electronic age verification scheme to unambiguously confirm the consumer’s age. The Government does not clarify the preferred system of age verification but states that the enforcement authorities are interested in the development of age verification technologies, such as that under development by the Digital Policy Alliance and British Standards Institution
  • Since EU Member States are taking different approaches to age verification systems, it will be for UK companies selling into other Member States to establish and meet those requirements
  • Manufacturers and importers will have opportunity to specify information that they consider to be confidential when they submit notification. MHRA will publish all non-confidential information on a designated website in line with the requirements of the TPD2 Article 20
  • The Government will not require businesses to nominate a named person to collect any adverse events information. MHRA will facilitate the reporting of adverse events (by consumers and businesses) through a dedicated reporting channel on the Yellow Card portal which will ensure that concerns are directed to the relevant enforcement body for assessment and action. The Regulations will, however, obligate businesses to investigate and report such incidents to the Competent Authority along with the outcome of any action that may have been taken in line with current requirements in TPD2 Article 20. The authority being passed to MHRA makes PAS 54115 an irrelevance and broadly removes the need for VPMS systems
  • The Government clarifies that powers given to secretary of state in relation to (transposed) article 20(11) cover the situation where a product conforms to all the product safety standards in the TPD2, but despite this, the product is found to be a serious risk or potential serious risk to human health, for example due to one of the substances inhaled
  • Enforcement definitions for e-cigarette products will be reduce to ‘electronic cigarette’ and ‘refill containers’. e-cigarettes and refill containers will be required to be labelled with the shorter version of the warning, i.e. ‘This product contains nicotine which is a highly addictive substance’. There may be exemptions to this for products not containing nicotine, although the Government is seeking further clarification on the matter
  • The government has proposed to charge £220 for a new notification£110 for a modificationand an annual service charge of £60 per notification. The fees structure is currently under consultation phase and a decision will be taken once consultation has ended.  The £220 fee is simply for registration and in no way reflects the other costs associated with a submission. These include the high costs of emissions teststoxicological evaluation and other associated costs. Getting a product approved will still be a lengthy process with associated costs in man hours, as well as the costs of the testing regime
  • Retailers and importers have until May 2017 to sell through old stock, although this applies only to products manufactured prior to November 2016. Product registration opens November 2016 and products not making this deadline are likely to be delayed for 6 months. Therefore, this is a very important deadline in terms of continuity of availability past May 2017
  • Finally, we are frequently asked about the stipulations in regards to bottles. At present the consultation is still open and two options are provided:
    • 1) a refill container possessing a non-detachable nozzle at least 1cm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically. We believe that the limit of 20 drops per minute is based on technical standards adopted by the French standards setting authority AFNOR
    • 2) a docking system which only releases refill liquids when the electronic cigarette and refill container are connected
  • It is currently unknown whether option 1 means a bottle in its existing form (for plastic dropper bottles), where you can squeeze the bottle to speed the flow, or if it refers to a bottle that cannot be squeezed. The ‘common current belief’ is that it is bottles in their current form, but nozzles will need to be fixed and non-removable. We will verify
    this as soon as we know more

 

If you would like any further information on the above article or any help related to TPD compliance please email compliance@xyfil.com or call 01772 888 778

Leave a Reply

Your email address will not be published. Required fields are marked *