Last month we took a close look at the Brexit situation and how vaping was likely to change as a result of it, and we have had a great deal of positive feedback and follow up questions after that article. So in an upcoming Vapouround article this month, I want to go over a couple of items. Enforcement action for non-compliant TPD, why compliance is not just a box ticking exercise and things to look out for in Belgium.
We look after quite a few customers that have products listed in Belgium and the authorities there have been active in recent months getting the notifications into a shape they like. A couple of key points, initially it looked like they had a much tighter demand on banned substances than the UK, but after quite a bit of back and forth with them it’s the same list as the UK, but just some different interpretation and technical terms being used.
But the other key point is that the Belgium authorities would like to know who is responsible for distribution of each product in Belgium, and they want that information providing through the XML as part of the product notification. So we have been updating the technical files for a number of our customers and re-submitting products. There was a minor difference in how they want the branding and sub branding submitting, including nicotine strengths, so we have been updating those at the same time.
So all in all if your in Belgium you need to be checking your submissions and probably updating them.
We have been saying it for years, although its obviously self-serving advice for us, that compliance is not just box ticking, the initial submission of notifications was fairly formulaic and we have seen quite a few low cost operators out there offering compliance on the cheap, or companies cobbling together tox data where they can and fudging together notifications. However some of those products are going to start to come undone as notifications and TPD move away from just the admin to an age of complexity, we are seeing the age of enforcement and scrutiny upon us.
Just in the past 5 or 6 months we have engaged in some pretty rigorous toxicology assessments for compounds that are critical to some successful flavours but on the face of it may be banned. By engaging in highly detailed toxicology reports that look at the overall exposure from various vaping patterns, metabolism of the products systemically and in the lung, and excretion of those metabolites, we have been able to look at the safety of certain compounds and set detailed exposure limits. This has always been part of toxicology assessments but the detail of these reports is now extremely advanced, and the methodology has been presented at the AIT (Association of Inhalation Toxicologists) conference in the USA.
We are also doing the same for degradant products as although this has some distance to go the regulators are taking a strong interest in moving beyond reporting and looking for high peaks but start to put real safety protocols together. So my concern is that as the regulations mature the requirements for compliance will become increasingly complex and many companies will not have the regulatory experience to manage the situation. The industry has fallen into the trap of viewing compliance as a one hit task, rather than an ongoing responsibility.
These are the key regulatory shortcomings I keep seeing:
We have seen quite a bit of enforcement action in the past few month, on untested short fills, online retailers breaching pack sizes, lots of branding issues with passing off and appealing to children, and devices not being notified, RDAs in particular. So if you think these might apply to you and your business, now’s a good time to get things sorted.