This is just one week in the UK’s journey to leave the EU, a voyage that could take two years or more. Instability abounds, both for the UK and any European countries that choose to follow our lead, or remain within an already fractured EU. The question everyone within the Vape Industry is asking is how does this affect our compliance and our responsibility to the TPD?
Our resident TPD expert, Stephen Buss, answers your questions…
As we know, Stephen is considered one of the leading experts on the TPD regulations with regard to the Vape Industry, as an ex BAT scientist he has a wealth of transferable experience within the Tobacco industry relating specifically e-liquid chemistry. His technical background was gained through experience as a scientist in Pharmaceutical New Product Development for SmithKline Beecham, Global Scientific Strategic Research Management for British American Tobacco & a combination of Sensory, Consumer & Market Research Project/Account Management & planning for Food & Drinks Research Agencies Worldwide. You will have read his articles in many a UK or US Vape Magazine.
Now that the UK has voted to leave the EU does this mean I won’t need to do my TPD compliance?
Numerous people and companies have asked us this so far and the answer is a quite straightforward, NO, nothing changes with regard to the TPD. This is already law, and will be fully enforced in November. It will take a minimum of 2 years for full UK withdrawal, at which point the compliance regulations will still apply to anyone wanting to sell through to the rest of the EU, and within the UK we will have regulations of our own which are likely to be even more stringent than the existing EU TPD requirements. There is a debate planned in the House of Commons in July and we will be sending representatives to the pubic galleries to report on not only the content but the potential outcomes from these discussions.
Will I still be able to sell my TPD compliant products to the UK after or during this Brexit time?
If your products are genuinely TPD compliant, and notifications have been approved in some way shape or form by the MHRA, it is likely that the UK will implement a compatible system, which will allow you to fully migrate your compliance. Britain is one of the most highly regulated countries in the world with regard to consumer health, so whilst we should, in time, be able to rid ourselves of the more ridiculous and ill-fitting aspects of the TPD, it is likely the basic scientific framework will be the same and your TPD data will be fully transferable to any new system the UK decides to migrate to. The main advantage with a UK Brexit is that when we do re-visit article 20, we can pass motions to scrap the likes of parts of the advertising ban, the 2ml tank and 10ml bottle limits, the nicotine content limit (maybe) … I say maybe as the Scots voted to remain, and although I doubt they will be accepted by the EU we had a better justification for bumping up the nicotine concentrations in liquids as nicotine has a proven ability to maintain and improve upon the conditions associated with mental health conditions in humans. This is a bit political but out of my realms but Scotland has the highest concentrations of the population undertaking mental health treatment and this is great for justifying to UK Government that higher nicotine level containing liquids would only serve more advantageous to those switching from conventional combustible tobacco to liquid vapour delivery of nicotine.
The TPD requirement is to have an “EU natural” importer, and I’ve chosen someone in the UK… Should I choose someone else, perhaps from Germany or Italy, to be my importer?
No, definitely not! We will all still be members of the EU for at least another two years, so as long as you have already registered your EU importer this is perfectly acceptable. Choose your EU importer situated within your biggest market – if this is the UK your importer would ideally be based there. If you choose an importer somewhere else within the EU: for example let’s assume you went for your second biggest market and that was France… If France decides to follow the UK’s example and leave the EU, you will be in exactly the same position. So my advice is to ensure your named importer is in the country that represents your biggest market. The important thing is that you’ve named your importer, and that they are a current EU natural.
How do I know I’ve chosen the right compliance company to represent me?
Well that’s probably the best question I’ve been asked so far! As the regulations will not be enforced until November it’s an unpleasant and uncertain wait to find out whether your compliance company has been successful. There are however a number of questions you should ask yourself with regard to your chosen representative that would immediately highlight a bad compliance company… Firstly, has your chosen compliance company issued you with your submitter ID? This is an essential first step in the process of gaining compliance. Secondly, is your chosen company testing for emissions on the vapour phase? Whilst this tends to be the most expensive part of the process, it is the testing methods that generate the results of these types of test, what really matters to the MHRA is the methodology, this is essential. At Vape Compliance we only ever use a UK based laboratory that is both MHRA accredited and FDA approved, this adds the highest credibility to your scientific results and reporting. They have worked closely with the MHRA to devise a suitable methodology moving forward into the years ahead.
Is it too late to instruct a compliance company now?
No, it’s not too late; although this is something I would now agree should be a top priority for anyone wanting to continue selling e-liquids or devices into the EU after November. If you are a small retailer and you only sell other companies’ products you still have a liability to ensure those companies products are compliant and that you are even registered as a retailer … In this instance a good compliance company can provide Shop Audit Programmes with prices starting at approximately £2000. If, however, you are a large e-liquid or device manufacturer you really need to get a move on as the necessary emissions tests are time consuming and you really need to have the laboratory tests organised as quickly as possible, and the toxicological data in hand.
Are there any Compliance Companies to avoid?
Well it would be totally inappropriate for me to name any names and shame any games at this point, but again, there are a number of pointers to look out for… Is your Compliance Company also a manufacturer or retailer or have any affiliation with such companies? Do they supply ingredients into the industry and bind you to supply for notification and testing ownership? This is what is called a direct conflict of interest and will not sit well with the MHRA if the corners are cut off from the likes of the scientific testing and research presented. Has your Compliance Company “guaranteed” you that your products will “pass the TPD”? If so, what a load of nonsense! There are no guarantees that your products are fit for human consumption in the opinion of the MHRA until they have reviewed your data and any company who attempts to guarantee this should be utterly ashamed of themselves.
A good compliance company will highlight any red flags and steer you in the right re-formulation direction and not by offering a product they either manufacture or supply as an easy fix replacement. Do not mug yourselves off by these types of tactics, but if your e-liquid contains something implicitly harmful to vape by inclusion or generation, or if your chosen company’s analytical methodology is not adequate, you will fail to satisfy the MHRA.
We suspect they will reject approximately 80% of all submissions, so try to ensure your compliance is provided from a company with an excellent pedigree, and fitting methodology to satisfy the TPD requirements. One final negative pointer to look out for in any company you are considering or have already instructed is the typical dodgy salesman approach… We are often contacted by large e-liquid manufacturers who say they have found a company who offers money back TPD guarantees, and I would say to you the customer, beware, beware, beware! Adequate emissions testing is expensive for e-liquids, and even more expensive for devices, so any company who tell you they can do it for free, or a few hundred pounds per product, is definitely NOT in a position to get you through the TPD.
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Well we hope that has cleared up some of your immediate TPD issues. Whether you are small retailer with only one Vape shop, or a large manufacturer with multiple e-liquids, you all have a responsibility to the TPD, at a variety of different levels. Good business practice implemented straight away will ensure you will still be able sell your products to the EU market beyond November 20th.
Whether you decide to consult with Vape Compliance or any other Compliance company, do it sooner rather than later. We expect the MHRA will be looking to slim down the currently unregulated industry quite substantially in order to manage it a bit more effectively, so please take your responsibility to the TPD’s regulatory requirements very seriously, and do take some action before it is literally too late. CHECK your existing Compliance Company against the standards Stephen has recommended, or if you have still not addressed your TPD responsibility do so now by contacting us!
Everyone has a TPD responsibility to bear… From individual shop audits for independent retailers, to large scale e-liquids Technical and Toxicological Dossiers for huge manufacturers, we offer a level of service for everyone, so if you would like to know how Vape Compliance can help you, please contact me urgently for a specific quote: tilly@vapecompliance.com or check out our website www.vapecompliance.com for testimonials from the market leaders we work with.
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