20th May 2016, the date the revised EU Tobacco Products Directive comes into force, is fast approaching and the discussion is definitely heating up. With the possibility of a referendum on a British exit from the EU taking place as early as June 2016, and definitely happening by the end of 2017, many in the vaping community are citing the TPD as a good enough reason to leave the EU.
What is the EU Tobacco Products Directive (TPD)?
A regulation that originated in 2001 with the aim of reducing tobacco usage across the EU. The decision to regulate e-cigarettes as a tobacco related product was proposed in revisions to the TPD in 2014. Despite huge debate (and a legal challenge from UK based Totally Wicked) these proposed revisions are set to be enforced as from 20th May 2016. The TPD label regulations for E-liquids that contain nicotine.
The proposed changes to the EU TPD:
A great deal of uncertainty still exists around the impact that the TPD will have on the vaping industry and vaping community within the EU. The interpretation of a number of the changes is proving contentious and the enforcement of the regulations is also being called into question. The Competent Authority for the TPD in the UK is the Medicines & Healthcare Products Regulatory Agency (MHRA).
Summary of proposed changes:
- E-liquid (nicotine containing liquid) bottle sizes to be limited to 10ml
- Maximum size of cartridges/tanks to be limited to 2ml
- Nicotine strength of liquid to be limited to 2%
- Leak free refilling containers
- Consistent dose of nicotine
- Notification and submission of information of detailed product information and sales data
The reality for E-liquid suppliers:
You will no longer be able to supply E-liquid in bottle sizes above 10ml, which will inevitably incur higher production costs. The UK Government has allowed a period of grace until May 2017 to enable the sale of “old stock”.
E-liquids with a nicotine content of over 2% will no longer be saleable and it is widely believed that 18% will become the strongest e-liquid produced as suppliers build in a margin of error for testing purposes rather than risk non-compliance.
Stricter controls on the ingredients that can be used in E-liquids will undoubtedly reduce the number of flavours that you can afford to market.
Every e-liquid you wish to take to market will be subjected to an emissions test and will require a notification of the list of ingredients, detailing the chemical components in the e-liquid and the vapour, to be submitted to the MHRA six months before the product goes on sale. The cost for notification is going to be around £220 per notification for a new flavour, £110 for a modification to a flavour and then £60 per year ongoing.
This time consuming activity will again increase the overall costs of production and greatly increase the time it takes to get a new flavour to market. It has been estimated that notification costs alone will cost the industry around £1 million! At this stage, no figures have been put forward for testing costs.
Again the UK Government has allowed a period of grace. All new flavours will need to be notified as from 20th May 2016. Existing flavours will have to have notifications in place by November 2016.
What should action should you be taking now?
Order smaller quantities of printed labels for larger bottle sizes to ensure you are not left with thousands of unusable labels once the TPD comes into force. We specialise in ultra-short print runs so will be able to help with this.
Consider using variable print labels for those e-liquid flavours that are currently over 2% in strength. This will enable you to continue to buy printed labels in bulk for a particular flavour – just without the strength pre-printed on them. If you reduced the strength of the e-liquid to comply with the TPD the revised strength could then be overprinted onto the labels at a later date using a thermal transfer printer.
We would recommend keeping tight control on stock levels of any e-liquids that are over 2% in strength bearing in mind that as from May 2017 you will not be able to sell them.
Consider how you can improve the information that you currently provide on your packaging and labelling. Send us a sample of your existing label and we will review it and advise what information it should contain to meet the revised requirements.
Can we help?
If you have any questions or concerns about the impact of the EU TPD on your E-liquid business then please get in touch, call Chris on 01440 712273. We will be able to advise you on the best course of action to take to ensure your labelling complies with the Directive.