Xyfil-Bottles-TPD-Compliant

TPD stands for the Tobacco Products Directive. Article 20 of the European TPD came into effect on 20 May 2016 and brings with it new rules and regulations for advertising electronic cigarettes.

We want to give you a succinct breakdown of the directive using plain English, along with notes about how this directive is being put into law in the UK. For overseas readers, we recommend checking how the directive will be used by your national legislators.

Xyfil-Bottles-TPD-Compliant

The latest TPD rules ensure:

  • Minimum standards for the safety and quality of all e-cigarettes, refill containers and e-liquids
  • Information is provided to consumers so that they can make informed decisions
  • An environment that protects children from starting to use these products

The new TPD requirements to help enforce the above rules:

  • Restrict e-cigarette tanks to a capacity of no more than 2ml
  • Restrict the maximum volume of a nicotine-containing e-liquid for sales in one refill container to 10ml
  • Restrict e-liquids to a nicotine strength of no more than 20mg/ml
  • Require nicotine-containing products or their packaging to be child-resistant and tamper evident
  • Ban certain ingredients including colourings, caffeine and taurine
  • Include new labelling requirements and warnings
  • Require all e-cigarettes and e-liquids to be notified to MHRA before they can be sold

Key TPD Article 20 take away points for Producers:
1. Member States are responsible for making sure only e-cigarettes and refill containers meeting the directive are available on the market. Note: The UK Govt will not apply the TPD to 0mg nicotine-free e-liquids.

2. Manufacturers and importers are to submit notifications to the Member States for the products that they intend to place on the market. Notification is to be submitted 6 months prior to the product being available on the market. Note: If a UK notification already exists for your product, you do not need to submit a duplicate notification. Similarly, if your brand name is listed in the manufacturer’s notification for a product you are re-branding, you will not need to submit a duplicate notification.

3. It is important to submit your products for TPD notification. The MHRA submission fee for notification is £150. If substantial modifications or updates are required for the originally notified product, the fee is £80. The annual fee (payable each year on 1st April) is £60. At Xyfil, we can offer help for notification submission. Please contact us for more information.

4. Member states are to ensure that the requirements for the labelling and packaging of e-cigarette and refill container products are to be followed. E-cigarettes and refill containers must include an information leaflet regarding safe product use including:

  1. Instructions for use and storage and notification that it is not recommended for non-smokers or young people
  2. Contra-indications
  3. Warnings for specific groups
  4. Possible adverse effects
  5. Addictiveness and toxicity
  6. Contact details of manufacturer/importer and contact details within the union

5. E-cigarette and refill container product packaging must:

  1. List all ingredients by weight in descending order Note: The UK Gov’t states that where a flavour ingredient contains several component chemicals, it is acceptable to describe the ingredient on the product label by the flavour.
  2. Provide an indication of nicotine content and delivery per dose, the batch number and a recommendation to keep out of the reach of children
  3. Comply with Article 13 (no health claims or downplaying of negative health effects; no resemblance to food or cosmetic products; no claims about environmental advantages; no suggestion of economic advantages; no promotional discounts or free samples, etc.)
  4. State “This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers”. On small packaging, such as e-liquid packaging, the second sentence can be omitted. Note: if your e-cigarette product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement must still be applied.

Health warnings displayed on labelling and packaging to comply with Article 12 (‘This product damages your health and is addictive’) must appear on the 2 largest surface areas of the unit packet and outside packaging, as well as in specific warnings area. It must cover 30% of the packaging. Please note, this may change pending scientific developments.

6. New advertising regulations and restrictions must be adhered to:

    1. With the exception of industry targeted media, marketing communications with direct or indirect promotion of nicotine-containing e-cigarettes and their components, which are not licenced as medicines, are not permitted in the following media:
      1. Newspapers and magazines
      2. Internet display, email and text message advertising
      3. On-demand television and radio

      7. Manufacturers and importers need to submit annually (member states want to monitor for any gateway effect):

      1. Sales volumes (by brand and type)
      2. Data on the preferences of consumer groups including young people, non-smokers and the main current users
      3. The mode of sale of the products
      4. Executive summaries of any surveys carried out in respect of the above

      8. Member states must make all information submitted in the notification (see section 2 above) publicly available. Note: The UK Government has agreed to keep confidential details private, as long as it’s marked as confidential during submission.

      9. The MHRA are responsible for maintaining a system to collect information on the adverse effects from any product:

      1. If a customer reports these to the manufacturer/importer, as opposed to the MHRA, it is the companies responsibility to inform MHRA along with any remedial steps taken
      2. If any product is deemed unsafe, the secretary of state has the power to demand the product is removed from market if the manufacturer/importer has not taken remedial steps in light of risk to human health

9. In relation to the above points in section 9, if the Secretary of State has to intercede all information is to be sent immediately to the commission and authorities of other member states. The commission will ultimately determine if the measures taken are justified and if a product becomes prohibited in more than 3 member states on justified grounds, the Commission has the power to ban the product in all member states

Please note, the above points are an abridged version of the legal documentation. We strongly advise that you read the official Article documentation and seek advise from a legal professional if there is anything that you are unsure of.

 

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 us on +44 (0)1772 888 778

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