Product Standards: Difference between revisions

Cross Border Sales

Public Health England have uploaded a list of EEA Member States that have either confirmed they are permitting cross-border distance sales of e-cigarettes and/or tobacco products or are yet to confirm domestic rules in this area, and a list of registered retailers. All other Member States have banned cross-border distance sales, and it would contravene the law to trade in those countries. Businesses who intend to trade in countries where the sales confirmation, registration website or contact details are yet to be confirmed (TBC) are advised to contact the national authorities before commencing supply.

You can find more information, along with a link to the online registration form to be completed here.

Submitting a notification

Create an ECAS account

Apply for a submitter ID number

Ensure you have a ECAS account

 

Go to the EU-CEG website

 

In the tabs at the top select ‘Downloads’

 

Click the link that says ‘e-cigarettes and refills’. You will need an ECAS account to access this page. If you cannot see the information below, you will need to create an ECAS account, log in, and start again from step 2

 

You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’

Unless you have an AS4 Access point, you will need to click ‘XML Submission through web interface’ (if you do not know whether you have an AS4 Access point, or are not sure what one is, we recommend you use the web-interface option)

On this page you will find:

submit your XML through the web interface;

manage user accounts in the XML upload system (E-trustex)

A keystore (EUCEG_GUI_USER) to decrypt the messages received by the EUCEG system. (The ETRUSTEX tutorial gives you the information about how to use this keystore)

How to install the XML creator tool procedure (procedure to install the TDP XML creator tool.pdf)

Unless you wish to use a bespoke XML file creator, the Commission have provided one that is free for you to use. To access it, download the tpd-xml-creator-tool-1.1.3.zip and run the file named the tpd-xml-creator-tool-1.1.3.jar

Once you have created your XML files using the tool, you can upload them to the portal by following the instructions in ETRUSTEX tutorial.pdf.

Guidance on the content of notifications

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

Details of the information notifications are required to contain are set out by the Commission in the Data Dictionary (PDF, 888KB, 37 pages).

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

Product type guidance (PDF, 168KB, 3 pages)

Submission type guidance (PDF, 412KB, 3 pages)

Emissions testing guidance (PDF, 93.9KB, 3 pages)

Nicotine dose guidance (PDF, 74.2KB, 2 pages)

UK ingredient guidance (PDF, 265KB, 3 pages)

Labelling guidance (PDF, 85.2KB, 2 pages)

UK product presentation guidance (PDF, 41.2KB, 4 pages)

Annual reporting guidance (PDF, 35.9KB, 3 pages)

General advice on vigilance (PDF, 44.5KB, 2 pages)

General advice on due diligence (PDF, 42.5KB, 2 pages)

Fees

Invoices

Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.

Rebuildable devices come within the definition above and require notification. See the product type guidance for further advice.

‘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 TPD and do not have to meet its requirements. These products will continue to be regulated under the General Product Safety Regulations.

The requirements do not apply to ‘trade sales’, for example where you are selling industrial quantities of nicotine-containing liquid (typically over 25 litres) to another business and the sale is not directed to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.

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

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