TPD REGULATIONS - DIRECT GOV.UK!!!!

TPD REGULATIONS - DIRECT GOV.UK!!!!

Posted by direct gov on 25th May 2016

Overview

The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). Tobacco and Related Products Regulations 2016, which were laid before Parliament on 22 April 2016, implement the Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.

From May 2016, the regulations introduce requirements for producers of e-cigarettes and refill containers. A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Producers must submit information about their products to E-cigarette transition periods for producers (TPDsafety@mhra.gsi.gov.uk

Advice for retailers

If you sell e-cigarettes and / or e-liquids by retail to the general public, you need to be aware of the transition periods for implementation of the new rules:

20 May 2016 – 19 November 2016

No change.

20 November 2016 – 19 May 2017

You may continue to sell products you already have in stock during this period.

When sourcing new supplies of any e-cigarette or e-liquid product, ask your supplier whether the product complies with the requirements of the https://www.gov.uk/government/publications/tobacco-products-and-e-cigarette-cross-border-sales-registration

Submitting a notification

Notifications have to be submitted to https://webgate.ec.europa.eu/cas.

  • Apply for a submitter ID number, seehttp://ec.europa.eu/health/euceg/index_en.htm#fragment0
  • Guidance on the EU-CEG and how to complete these steps has been made available by the European Commission here

    We will provide further details of later stages here as soon as further functionality of the EU-CEG portal is made available by the European Commission.

    Guidance on the content of notifications

    The format and content of notifications are set out in Commission Implementing Decision (EU) 2015/2183 on e-cigarettes.

    Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.

    We are publishing below initial draft guidance to aid producers of e-cigarettes and e-liquids to prepare notifications for their products. This guidance has been developed by the UK and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers.

    Product type guidance - Product Type Guidance (Submission Type Guidance (Emissions Testing Guidance (Nicotine Dose Guidance (The Electronic Cigarettes etc. (Fees) Regulations 2016. The costs of notifications are as follows:

    Notification fee: £150

    Annual Fee: £60

    Substantial Modification Fee £80

    consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here.

    Labeling Guidance (Yellow Card reporting system

    Key terms

    The definitions of products that are subject to the new regulations are set out below.

    ‘Electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. E-cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

    Products that require a notification are limited to the e-cigarette product and component elements sold separately that specifically contain, or could contain, nicotine in the form of e-liquid. Therefore products such as disposable units and tanks will require a notification; however equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.

    ‘Refill container’ means a receptacle that holds a nicotine-containing liquid, which can be used to refill an electronic cigarette. These are more commonly known as e-liquids.

    Products that do not meet the definition (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) are out of scope of the General Product Safety Regulations.

    ‘Producers’ refers to any manufacturer; importer and/or those who re-brand any of the products covered by the above definitions as their own.

    Further information

    European Commission pages on tobacco policy – for the text of the Tobacco Products Directive and Implementing Acts, notes of Commission meetings, etc.

    Department of Health Consultation on the sale and manufacture of tobacco products

    This page will be updated as more details become available.

    Contact

    For more information on the regulatory framework, or to register for ongoing updates about the scheme, email info@mhra.gsi.gov.uk

    We will be updating this page with the latest information, register for updates