A shock announcement on Friday has confirmed the UK as the world's most vape-friendly country.
Just three weeks before the door closes for manufacturers to submit notifications under the new regulations, the MHRA announced that they would no longer require full ingredient disclosure from e-liquid manufacturers.
It's a move that will delight those who struggled to get their flavor suppliers to give up trade secrets but infuriate those who have invested a small fortune on toxicological work that now seems redundant. We anticipate that many more US e-liquid brands will now consider the UK as a territory worth doing business in.
MHRA sent an email to the industry Friday that included the following statement:
Commission Implementing Decision (EU) 2015/2183 states that ingredients present at a level below 0.1% of the final product formulation may be deemed confidential or a trade secret. Below that level, we will allow ingredients to be considered as confidential in the notification. As such, ingredients present at a level below 0.1% of the final formulation can now be described collectively in the notification by an umbrella term such as "strawberry flavouring"
In order to do this, companies will need to get hold of the following from their flavour suppliers:
Adequate assurance of quality and safety to allow the notifier to accept full responsibility for the product under s31(3)(g) of the UK Transposition of the Directive, and an assurance that the ingredient supplier would disclose the composition to the competent authority (MHRA) in confidence the event of a safety problem with the product.
MHRA recommend that companies also get written assurances that: "The ingredient complies with applicable EU food flavouring legislation Regulation EC 1334/2008.
The flavouring substances contained within the flavour are listed in the EU list of flavouring substances as defined by Regulation EU 872/2012.
The ingredient formulation does not include any substance banned under Article 7 of the Tobacco Products Directive.
Will flavoring companies be willing to provide this written assurance of safety? That much we will have to wait and see; but if they do, this massively reduces the regulatory burden for eliquid companies. Many in the US are already looking to relocate to the European Union in light of the FDA seeking a complete ban on the category; today's guidance from the UK will accelerate that trend, and we hear on the grapevine that one other EU Member State may follow suit.
Notifications for existing product lines are now due in three weeks, so there isn't much time. If you need more information, please email Peter Beckett using peter [at] publicpolicymatters [dot] com
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