E-cigarettes regulations for consumer products

E-Cigarettes regulations

 

As the national body responsible for the health promotion and improvement, health protection and prevention of illnesses and disease, the HSE has adopted a Tobacco Control Framework and given a commitment that all HSE campuses will be tobacco free. Our Tobacco Free Campus Policy helps change social norms around tobacco Our ability to implement the Tobacco Free Campus Policy, which is already in place in many hospitals and healthcare facilities, is increasingly facing difficulties arising from the use of electronic cigarettes (e-cigarettes) by staff and service users.

The HSE has a legitimate concern that because e-cigarettes resemble ordinary tobacco, their use may promote or re-normalise smoking and make it harder to implement our tobacco free campus policy. Furthermore, scientific testing indicates that the products vary widely in the amount of nicotine and other chemicals they deliver. At present we cannot say that e-cigarettes are safe; WHO is of the view that the safety of e-cigarettes has not been scientifically demonstrated and the potential risks they pose for the health of users remains undetermined. Manufacturers of oxygen supplies for hospitals have advised the health system that e-cigarettes pose a potential fire hazard in proximity to oxygen sources.

The HSE has now updated the National Tobacco Free Campus policy to the effect that the sale, advertising and use of e-cigarettes is not permitted within HSE facilities or on HSE campuses. E-Cigarettes in Smoking Cessation "The HSE is at the forefront of tackling the harm caused by tobacco in Ireland and is the largest provider of QUIT support services to smokers. We welcome any measures that will help reduce the tens of thousands of people disabled, killed or bereaved by cigarettes each year, and want to help every smoker to QUIT. While E-Cigarettes are a new and potentially helpful addition to the many proven QUIT supports and products available - the Health Service can only endorse products that are proven to be safe, and proven to be effective; e-cigarettes have not yet achieved either test." Context Ireland is recognised as a world leader in tobacco control but despite considerable success in reducing smoking prevalence over the last ten years (28% ->23%) smoking remains that leading preventable cause of chronic disease and mortality in Ireland; responsible for a range of respiratory diseases, cardiovascular diseases and cancers, and with over 5,800 people (~16/day) still dying each year from tobacco related disease.

There are still over 850,000 smokers in Ireland and 1 in 2 smokers continue to die from tobacco related disease, losing an average of 10 years of life. The best thing a smoker can do for their health is to quit smoking completely and quit for good. Smoking is a major cause of inequalities with smoking prevalence and the associated disease burden having a strong social gradient whereby the poorest, most disadvantaged sections of society are more likely to smoke and die younger. Yet, studies show that people who never smoke from the poorest backgrounds have much better survival than people who smoke from well off backgrounds. National Tobacco Control Policy " Tobacco Free Ireland" sets out a target of a Tobacco Free Ireland by 2025 i.e. smoking prevalence of 

 

 

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 come 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 TPDsafety@mhra.gsi.gov.uk

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.

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

Notifications have to be submitted to MHRA through a European Common Entry Gate (EU-CEG) notification portal made available by the European Commission.

Steps you can take now

  1. Create an ECAS account

  2. Apply for a submitter ID number

  3. 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 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, 181KB, 3 pages)

Submission Type Guidance (PDF, 455KB, 3 pages)

Emissions Testing Guidance (PDF, 101KB, 3 pages)

Nicotine Dose Guidance (PDF, 79.1KB, 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.

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