Hi, this post is purely a copy/paste of the 3rd MHRA update email for those who haven't yet signed up for updates (please see end of email). #VapeOn
Welcome to the third update email from MHRA’s e-cigarettes team.
Thank you for all your responses to the last email. We got a lot of feedback about the transitions flowchart, and have been working to include more detail on the requirements for producers of e-cigarettes and e-liquids (manufacturers and importers and those who rebrand these products as their own), which we will send out soon. We will also be sending out separate guidance for retailers. This will make it clear that retailers do not need to notify the products they sell unless they are also a producer of the product.
In our next email, we will be releasing a number of guidance documents, which we hope will be able to answer many of your outstanding questions. In the meantime however, we have three important updates to share with you.
Tobacco and Related Products Regulations 2016
The Government today published the Tobacco and Related Products Regulations 2016 (SI No. 507) (TRPR) implementing the revised Tobacco Products Directive (Directive 2014/40/EU). The new rules will come into force on 20 May 2016. Part 6 sets out the requirements for e-cigarettes and e-liquids (refill containers).
A copy of the regulations can be viewed on: http://www.legislation.gov.uk.
Guidance on what this means for producers of e-cigarettes and e-liquids, and your obligations under the TPD and TRPR, can be found on our website.
The European Commission has released new information on how producers of e-cigarettes and e-liquids can apply for a Submitter ID on the European Common Entry Gateway (EU-CEG). This ID will be required in order notify your products.
As per our previous email, you will need to create a European Commission Authentication Service (ECAS) account first, which you can do here.You can now download a registration form for a Submitter ID, which you can complete and return to the European Commission. Once your form has been submitted, the Commission will start the process of assigning you an ID.We will update you with further news on the next steps in this process as we receive them.Refill mechanismsAfter receiving feedback from the UK and other member states earlier in the year, the European Commission has released an Implementing Decision on the technical standards for the refill mechanism of electronic cigarettes, which you can read here.
The Commission have confirmed that refillable electronic cigarettes and refill containers can only be placed on the market if the mechanism by which they are refilled meets one of the following conditions:
The Decision also sets out the information that must be included in the instructions for use of the product.
(a) It entails the use of a refill container possessing a securely attached nozzle at least 9 mm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected to atmospheric pressure alone at 20 °C ± 5 °C; (b) it operates by means of a docking system which only releases refill liquids into the tank of the electronic cigarette when the electronic cigarette and refill container are connected.
In this Decision, The Commission have updated the requirements to better align with industry needs. For example, the standards now specify that nozzles must be ‘securely attached’ as opposed to ‘non-detachable’, and the minimum length of the nozzle has been shortened from 10mm to 9mm.
Thank you to all those who took part in the consultation process, as your responses have helped shape the final draft of the Implementing Decision. An update regarding our other consultation on regulatory fees for E-cigarettes will be released in our next email early next week.
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We look forward to hearing from you
Mark WilcoxCampaigns Specalist Medicines and Healthcare products Regulatory Agency151 Buckingham Palace Road, London SW1W 9SZ, UK Telephone: 020 3080 6069