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Talk to our advisor’s At SWITCH we pride ourselves on our high quality Staff Training in order to provide both old and new customers the very best pre-sales advice, and ongoing support.
Tobacco and Related Products Regulations
Consumer Guide to
https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-productsPreliminary guidance on how to get an e-cigarette on the market in the UK, including the notification scheme and reporting problems with e-cigarettes.
Contents
Overview
Putting a new product into the UK market
Products already in the UK market
Advice for retailers
Nicotine Base Liquid
Submitting a notification
Guidance on the content of notifications
Fees
Labelling your product
Reporting problems with e-cigarette products
Advertising
Key terms
Further information
Contact
Overview
The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). MHRA is responsible for implementing the majority of provisions under Article 20 and has been designated as the competent authority for the notification scheme for e-cigarettes and refill containers in the UK.
The TPD introduces new rules which ensure:
minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
that information will be provided to consumers so that they can make informed choices
an environment that protects children from starting to use these products
The UK Tobacco and Related Products Regulations 2016, which were laid before Parliament on 22 April 2016, implement the TPD in the UK, and came into force on 20 May 2016. 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 MHRA through a European Common Entry Gate (EU-CEG) notification portal.
Details of when producers need to submit a notification can be found in the document below. E-cigarette transition periods for producers (PDF, 317KB, 1 page)
If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.
Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers have until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.
When MHRA is satisfied that a product notification is complete and complies with the TPD, we will publish all non-confidential information. Producers will be able to specify information that they consider to be confidential when they submit a notification.
The TPD does not cover nicotine-containing products that are authorised as medicines.
Putting a new product into the UK market
From 20 May 2016 onwards, producers of new e-cigarette and refill container products will need to submit a notification to MHRA 6 months before they intend to put their product on the UK market.
There are transitional arrangements for the period between 20 May to 19 November 2016. During this period, applications for new products which companies intend to put on the market must be made at least one day before they are sold for the first time.
A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.
Products already in the UK market
Producers of all e-cigarettes and refill containers that are covered by the TPD and are on the market before 20 May 2016 will have until 20 November 2016 to submit a notification to MHRA. After that date producers may only sell batches of a product that does not comply with the TPD requirements if the batch was produced before 20 November 2016.
Requirements for e-cigarette producers to report safety concerns
E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken. E-cigarette producers should notify the MHRA by email to [email protected]
Advice for retailers
If you sell e-cigarettes and / refill containers 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 refill container products, ask your supplier whether the product complies with the requirements of the TPD. If the answer is no, be aware that you may only sell the product until 19 May 2017.
On 20 May 2017
You will need to remove from sale any remaining stocks of products that do not comply with the TPD.
From 20 May 2017
When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published on the MHRA website. A link will be made available here when the web page goes live.
Only once a product is approved with a unique identifier number can it be sold to members of the public. The TPD took effect on 20th May 2016 and all non TPD compliant products are to be removed from the market by 20th May 2017.
The legal responsibility to ensure compliance with the legislation lies with both the producers and the suppliers (retailers). It should be noted that after the implementation, the Secretary of State reserves the right to force suppliers to cease trade of any non-compliant products and impose appropriate fines. Therefore SWITCH advises retailers to make sure they are well briefed on the new rules to ensure they comply.
Some of the considerations for sale under the TPD are given in this leaflet, Discover also how SWITCH has been actively working towards this new framework and how we will help you to continue to to use our vaping products moving forward……..
WHAT ISTHE TPD?
The EU Tobacco Products Directive or TPD, is a new regulation that has a number of implications for both e-liquid manufacturers and retailers. Part of its aim is to implement the
regulation of e-cigarette and e-liquid manufacturing, testing
and sales across Europe. In order for a product to be
compliant, all the standards of the TPD must be met, documented and the evidence presented to
the Medicines and Healthcare Products
Regulatory Agency (MHRA).
Since the introduction of TPD, e-liquid manufacturers need to ensure that their products not only fully comply with rigorous safety standards, but also that the ingredients and manufacturing processes they use are of the highest industry standard.
More specific restrictions include nicotine concentrations above 2% (weight/volume) and e-liquid bottles above 10 ml no longer being available. Tanks will also be restricted to 2 ml capacity.
Retailers of e-liquids and hardware are responsible for the products they sell, weather bought inside or outside the EU.This means each product put on the market must be notified to the MHRA a minimum of 6 months in advance. It is therefore vital that retailers have an understanding of the legal requirements of the TPD and protect themselves from non-compliant products by performing due diligence. The best way to do this is to only buy products registered with the MHRA.
Retailers must also bear in mind that since 20th May 2016 the industry as a whole has been prohibited from advertising on-line and via email including sales promotions. Websites and communications with customers must be purely factual in nature.
At SWITCH, we are actively working towards compliance and have already implemented a large number of changes in preparation for the TPD.
We are also participating in discussions with several regulation bodies to ensure our
understanding is in line with the latest developments.
We are working hard to ensure that we can continue to supply e-liquids that have been lovingly crafted to create unique flavour blends that cater for the ranging
tastes of Vapers in the UK and that also
meet the requirements of the new regulations.
For more information or if you have any questions, our team will be happy to help.
If you cannot find the product on the MHRA website, ask your supplier to confirm that the product complies with the TPD and has been notified to MHRA. If a producer has not notified the product or it does not comply with the TPD, they may not supply it to you.
Are you also a producer?
As a retailer, you do not need to notify any products you sell unless you are also a ‘producer’ of the product.
A producer is anyone who manufactures or imports e-cigarette or refill container products and anyone who re-brands them as their own. If you qualify as a producer, please see the transition period guidance for producers above.
If you import or re-brand products, check with your supplier whether they have already made a UK notification for the specific product you sell. If they have done so, you do not need to submit a duplicate notification.
Nicotine Base Liquid
The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to end consumers (irrespective of whether the end consumer intends to modify the product).
The requirements do not apply to ‘trade sales’ i.e. where you are not selling direct to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.
The application of all TPD requirements are subject to transitional provisions.
Cross Border Sales
From 20 May 2016, you need to register your business if you supply e-cigarette products via cross-border distance sales, for example online sales.
This applies to:
businesses established in the UK selling e-cigarettes and / or refill containers to consumers in another EEA state (European Economic Area – the 28 EU Member States plus Iceland, Liechtenstein and Norway)
businesses established in the EEA or third country selling to UK consumers.
Business to business sales, that is sales not direct to consumers, do not need to be registered.
Registration is a legal requirement under the TPD. Without confirmation of registration businesses must not supply a relevant product to a consumer via a cross-border distance sale.
You can find more information, along with a link to the online registration form to be completed here
Submitting a notification
Applying for a Submitter ID and ECAS account
Notifications have to be submitted to MHRA through a European Common Entry Gate (EU-CEG) notification portal made available by the European Commission.
Create an ECAS account
Apply for a submitter ID number
Guidance on the EU-CEG and how to complete these steps has been made available by the European Commission here
Submitting a notification
Once you have an ECAS account and Submitter ID number, you can continue with the application process. The European Commission have published some guidance to help you with this. You can find this guidance by following the steps below:
Ensure you have a ECAS account and EC-ID number
Go to the EU-CEG website
Scroll down to the blue ‘browse the theme’ table and click ‘technical documents’
At the bottom of the page, click the link that says ‘For electronic cigarette and refill container stakeholders’. 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 and log in
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:
The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to:
submit your XML through the web interface;
read the encrypted messages sent by EU-CEG; and
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)
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
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 that 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:
Contacts
Should you encounter technical difficulties, please contact [email protected] (including in your message a ‘print screen’ of the window where the problem appears)
For other general matters related to the functioning of the EU-CEG, but not to your request, please contact [email protected]
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 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)
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, 256KB, 2 pages)
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
The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. The costs of notifications are as follows:
Notification fee: £150
Annual Fee: £60
Substantial Modification Fee £80
MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here.
MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.
Labelling your product
Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products. Additional advice on labelling or e-liquid products is available here - Labelling Guidance (PDF, 85.2KB, 2 pages)
If your product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘This product contains nicotine which is a highly addictive substance’ must still be applied.
To provide clarity for consumers, we recommend adjacent wording (not part of the boxed warning) to the effect that the warning applies when the product is used as designed and charged / filled with nicotine-containing liquid. We are also seeking further clarification on this from the European Commission.
Reporting problems with e-cigarette products
From the 20 May 2016 consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card reporting system
Advertising
Guidance on the e-cigarette advertising provisions of The Tobacco and Related Products Regulations 2016 has now been published by the Department of Health. They expect that the Committee of Advertising Practice (CAP) will consult on further detailed guidance shortly and will work with them to ensure the consistent application of the law which requires that businesses do not procure or place any advertising that promotes or indirectly promotes e-cigarettes, as defined in the legislation. CAP will make further announcements on its plans for consultation in due course.
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 TPD and do not have to meet its requirements. These products will continue to be regulated under 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 [email protected]
We will be updating this page with the latest information, register for updates
SWITCH are pro-actively dealing with the requirements if the TPD to ensure we continue to provide our customers with unique eliquid flavour blends and high quality hardware post regulation.
As a responsible business, SWITCH already meets many of the requirements however, where changes or improvements are needed, we are making huge strides towards compliance. This includes tightening up procedures and actively participating in discussions with several regulatory bodies.
SWITCH are members of the Independent British Vape Trade Association (IBVTA) which has been formed to represent all responsible independent vaping businesses in the UK. Being independent means all members are free from any ownership or control by tobacco or pharmaceutical companies so providing credibility in this consumer driven industry. SWITCH relies on the science and regulatory committee which provides credible knowledge and guidance to support the independent vaping sector and promote constructive interactions between this industry sector and the scientific community.
SOME OF THE WAYS WE ARE PREPARING:
MOVING FORWARD
SPECIFIC CONSIDERATIONS FOR SUPPLY OF E-LIQUIDS:
• E-liquids must be free from diacetyl and acetyl propionyl with certification from an accredited laboratory. These components are scientifically proven to be harmful when inhaled.
• Toxicological risk assessment of all ingredients by a qualified toxicologist.
• Characterisation of emissions from e-liquid by an approved method.
• Full traceability of ingredients to source.
• Use of pharmaceutical grade PG, VG, nicotine and food grade flavourings only.
• E-liquids must not include any chemical classified as carcinogenic, mutagenic, reproductive toxicant, respiratory sensitiser or specific targeted organ toxicant (STOT).
• Packaging and labelling have to be compliant with the Classification of Labelling and Packaging rules and include a specific warning as given in the TPD.
• Certified nicotine concentration for each batch to within +10% of stated concentration.
Another effect on the retailer is that the number of flavours available across the industry will likely reduce and the rate of new hardware innovation will slow down.
Tel: 029 21153175
