MHRA Update Email #10: Flavours and Kits

Hi all, this is a Copy/Paste of the latest MHRA email on UK/EU Vaping regulations for those who don't get the email.
Medicines and Healthcare Products Regulatory Agency

Hello from the MHRA e-cigarettes team.
In our email last week, we told you that we had received more than 1,000 notifications, and encouraged you to start submitting your own. We now have more than 2,000 notifications in our system, over twice the number received by any other member state. Thank you to everyone who has put in the time and effort to start submitting their notifications well before the deadline, and a reminder to those of you who are still thinking about starting the process that there are only three more weeks until the deadline of 19 November.  
After 19 November 2016 no non-compliant products can be produced, and all compliant products that continue to be manufactured or imported must have been notified. For products to be fully compliant, they must be in compliant packaging, as per regulation 37 of the Tobacco and Related Products Regulations 2016 (TRPR).  For further advice, see our labelling and presentation guidance documents. 
Retailers will have until 19 May 2017 to sell off any remaining non-compliant stock, and are advised to read our advice for retailers. More information on these deadlines, including the transition periods for producers can be found on our website.

Confidentiality of Flavours
We have received a number of comments regarding the confidentiality of flavour ingredients produced by third party ‘flavour houses’ and are issuing the following guidance:
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 these cases, the notifier must gain the following from the ingredient supplier: 
(i) adequate assurance of quality and safety to allow the notifier to accept full responsibility for the product under s31(3)(g) of the TRPR and 
(ii) 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.  
Notifiers must satisfy themselves as to the safety and quality of their product but may wish to seek assurances that:
a) the ingredient complies with applicable EU food flavouring legislation (Regulation EC 1334/2008).  
b) the flavouring substances contained within the flavour are listed in the EU list of flavouring substances as defined by Regulation EU 872/2012
c) The ingredient formulation does not include any substance banned under Article 7 of the Tobacco Products Directive.  

Product type - devices and kits
Some producers describe a pack containing the parts of an e-cigarette such as a tank and a battery as a ‘kit’.  However, for the purposes of notification it is an e-cigarette.  A kit contains two or more products including different e-cigarette devices and / or different refill containers / cartridges.  See our product type guidance for more advice on this.   

Any other queries
As ever, if you have any technical enquires about the e-cigarette notification scheme under the Tobacco Products Directive, or the work of the MHRA, please send them to our official enquiries inbox:  info@mhra.gsi.gov.uk
Thank you for your time in reading and sharing this email with your contacts. We look forward to hearing from you.
Kind regards
Mark Wilcox
Campaigns Specialist
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK 
Telephone: 020 3080 6069

No comments:

Post a Comment

All comments are the responsibility of the poster and may be subject to moderation before release.