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Product Standards: Difference between revisions

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__TOC__
__TOC__
=Foreword=
''But the products have no standards'' is a frequent comment from clueless misinformed members of the Public and from malicious campaigning groups. This section will demonstrate that Standards do exist, and are in fact robust in nature and extent. As the products are relatively new, standards are continually evolving to reflect rapid product evolution. The initial passage refers to the standards implemented in the UK. later sections will include entries from other parts of the World.
=In brief=
Just links to the relevant standards:
*[https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf EU TPD Full text]
*BSI, the business standards company, has collaborated with the Electronic Cigarette Industry Trade Association (ECITA) to develop PAS 54115 Vaping products, including electronic cigarettes, e-liquids, e-shisha and directly-related products – Manufacture, importation, testing and labelling – [https://shop.bsigroup.com/ProductDetail/?pid=000000000030303130 Guide] (paywalled). 


=About=
=About=
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# In the tabs at the top select [http://ec.europa.eu/health/euceg/download_en ‘Downloads’]
# In the tabs at the top select [http://ec.europa.eu/health/euceg/download_en ‘Downloads’]
#  
#  
# Click the link that says ‘[https://circabc.europa.eu/w/browse/7dedde5d-b276-40f6-8d21-ccf98df87d46 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
# Click the link that says ‘[https://circabc.europa.eu/w/browse/7dedde5d-b276-40f6-8d21-ccf98df87d46 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 [https://webgate.ec.europa.eu/cas/wayf?loginRequestId=ECAS_LR-21723079-0mO1Gig6at8PBf8vSY2n1oUJnf9HYLhbvkVyoNvTlnkB69ivYg1Hkn5TyrId4tYYPoG88doLTVcvrZvaoynNpm-Jj71zxYb8yrdaMmFt4gSYi-5dNULQGlUEnYvmsXlu1gzzL38AUrzukRKdfOsoNiHSgy&caller=%2Fcas%2Flogin 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’
# You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’
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# On this page you will find:
# On this page you will find:
The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to:
*The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to:
submit your XML through the web interface;
submit your XML through the web interface;
read the encrypted messages sent by EU-CEG; and
*read the encrypted messages sent by EU-CEG; and
manage user accounts in the XML upload system (E-trustex)
*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)
*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)
*How to install the XML creator tool procedure (procedure to install the TDP XML creator tool.pdf)
The XML creator system (tpd-xml-creator-tool-1.1.3.zip)
*The XML creator system (tpd-xml-creator-tool-1.1.3.zip)
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
*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.
*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.


Please note MHRA does not run the notification portal or XML creator, and the steps above are for guidance only. If you have any difficulties, please contact the portal’s technical team directly via the email addresses below:
*Please note MHRA does not run the notification portal or XML creator, and the steps above are for guidance only. If you have any difficulties, please contact the portal’s technical team directly via the email addresses below:
 
=EU-CEG Contacts=


EU-CEG Contacts
Should you encounter technical difficulties, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a ‘print screen’ of the window where the problem appears)
Should you encounter technical difficulties, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a ‘print screen’ of the window where the problem appears)


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For other general matters related to the functioning of the EU-CEG, but not to your request, please contact SANTE-EU-CEG@ec.europa.eu.
For other general matters related to the functioning of the EU-CEG, but not to your request, please contact SANTE-EU-CEG@ec.europa.eu.


Guidance on the content of notifications
=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.
 
The format and content of notifications are set out in the [http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015D2183 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).
Details of the information notifications are required to contain are set out by the Commission in the [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/615094/TPD_submission_data_dictionary_electronic_cigarettes_1.1.1__002_.pdf 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.
Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in the [http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.101.01.0015.01.ENG&toc=OJ:L:2016:101:TOC Commission Implementing Decision (EU) 2016/586] of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.


We have published below guidance to aid producers of e-cigarettes and refill containers 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.
We have published below guidance to aid producers of e-cigarettes and refill containers 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 (PDF, 168KB, 3 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544092/2_Product_type_disc_paper_final.pdf Product type guidance] (PDF, 168KB, 3 pages)


Submission type guidance (PDF, 412KB, 3 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544091/1_Submission_type_disc_paper_final.pdfSubmission%20type%20guidance Submission type guidance] (PDF, 412KB, 3 pages)


Emissions testing guidance (PDF, 93.9KB, 3 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544094/3_Emissions_disc_paper_final.pdf Emissions testing guidance] (PDF, 93.9KB, 3 pages)


Nicotine dose guidance (PDF, 74.2KB, 2 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544095/4_Nicotine_Dose_disc_paper_final.pdf Nicotine dose guidance] (PDF, 74.2KB, 2 pages)


UK ingredient guidance (PDF, 265KB, 3 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/682739/Ingredient_guidance_final_draft_011116.pdf UK ingredient guidance] (PDF, 265KB, 3 pages)


Labelling guidance (PDF, 85.2KB, 2 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/520559/Labeling_Guidance.pdf Labelling guidance] (PDF, 85.2KB, 2 pages)


UK product presentation guidance (PDF, 41.2KB, 4 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/561810/Presentation-Guidance__1_.pdf UK product presentation guidance] (PDF, 41.2KB, 4 pages)


Annual reporting guidance (PDF, 35.9KB, 3 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/609686/Annual_reporting_guidance_Apr_17.pdf Annual reporting guidance] (PDF, 35.9KB, 3 pages)


General advice on vigilance (PDF, 44.5KB, 2 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/771488/GENERAL_ADVICE_ON_VIGILANCE.pdf General advice on vigilance] (PDF, 44.5KB, 2 pages)


General advice on due diligence (PDF, 42.5KB, 2 pages)
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/771489/GENERAL_ADVICE_ON_DUE_DILIGENCE.pdf General advice on due diligence] (PDF, 42.5KB, 2 pages)


If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation.
If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation.
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The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.
The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.


Fees
=Fees=
The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here.
The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here.


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MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.
MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.


Invoices
=Invoices=
MHRA will send an invoice to each company for the notification fees due in relation to all products for which information has been submitted via the EU-CEG. Payment of this invoice is due immediately upon receipt.
MHRA will send an invoice to each company for the notification fees due in relation to all products for which information has been submitted via the EU-CEG. Payment of this invoice is due immediately upon receipt.


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Swift Code NWBKGB2L
Swift Code NWBKGB2L
IBAN GB68NWBK60708010004386
IBAN GB68NWBK60708010004386
Further information
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.
=Further information=


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 e-cigarette products such as disposable units and tanks will require a notification; however e-cigarette equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.
New info from CEN


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.
New CEN Technical Report: Electronic cigarettes and e-liquids - constituents to be measured in the aerosol of vaping products
CEN has drafted a technical report for electronic cigarettes and e-liquids designed to reassure users, encourage good products and support the development of this growing market.


Rebuildable devices come within the definition above and require notification. See the product type guidance for further advice.
The CEN Technical Report ‘Electronic cigarettes and e-liquids - Constituents to be measured in the aerosol of vaping products’ [https://standards.cen.eu/dyn/www/f?p=204:110:0::::FSP_PROJECT:65461&cs=11304D006B6DAFFEE8110B2710FD7478A (CEN/TR 17236:2018)] has recently been published and provides a list of constituents of interest. These constituents have been proposed for aerosol measurement for the purpose of regulatory submission under [https://publications.europa.eu/en/publication-detail/-/publication/025cab37-e4fd-43da-b4f8-7183ccf0f1b6/language-en Directive 2014/40/EU], which concerns the manufacture, presentation and sale of tobacco and related products.


‘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.
They apply to:


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.
prefilled products such as disposable e-cigarettes and refill cartridges,
e-liquids sold in refill containers,
the following categories of hardware: coils or other heater elements of the vaping product, atomisers, rebuildable atomisers and all open tank or dripper products with inbuilt atomisers, including clearomisers.
The work has been led by the recently established technical committee [https://standards.cen.eu/dyn/www/f?p=204:7:0::::FSP_ORG_ID:1958025&cs=1076CCD77AC4703562C429855ED92DFA6 CEN/TC 437] “Electronic cigarettes and e-liquids”, who will develop technical standards for electronic cigarettes and e-liquid products. These standards will provide a common framework for all electronic cigarettes and e-liquid products sold in all EU markets. This work also aims to increase the safety of all the European users, by setting consistent safety and quality standards of the products and improving consumer information across all EU Member States. These documents, recognized and applicable in all CEN members’ countries, will give advice and help manufacturers, importers, exporters and distributors to adhere to standardised safety and quality requirements.


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.
[https://standards.cen.eu/dyn/www/f?p=204:110:0::::FSP_PROJECT:65461&cs=11304D006B6DAFFEE8110B2710FD7478A CEN/TR 17236:2018] was developed by [https://standards.cen.eu/dyn/www/f?p=204:7:0::::FSP_ORG_ID:1958025&cs=1076CCD77AC4703562C429855ED92DFA6 CEN/TC 437] “Electronic cigarettes and e-liquids”, whose secretariat is held by [https://standards.cen.eu/dyn/www/f?p=CENWEB:16:0::::FSP_ORG_ID:2764&cs=166C8F8D81765B2FE0B596C2F3E36874A AFNOR] – the French national standardization body.


‘Producers’ refers to any manufacturer; importer and/or those who re-brand any of the products covered by the above definitions as their own.
For more information, please contact [http://cdalier@cencenelec.eu Claire DALIER]


Sources of further information
=external links=
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.
https://www.gov.uk/government/collections/e-cigarettes-and-vaping-policy-regulation-and-guidance
[[Category:Safety info]]
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