Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697642474620.pdf (Australia)
Inquiry: The Tobacco Harm Reduction Focus on UK/EU regulations Tobacco Harm ReductionSubmission 169 Introduction Following the introduction of early electronic cigarette products to the UK market in 2005, significant developments in control and legislation have been made throughout the industry.

Over this time, attitudes towards the use of E-cigarettes have changed as increased studies have helped highlight the benefits of their use an alternative to smoking.
UK Industry Development The key developments are illustrated in Figure 1 and are summarised below.

Figure 1 - Key Developments UK Initial Market The first e-cigarette was introduced to the UK and Europe in around 2005, following Chinese innovation, and sold as unregulated products.

A rapid uptake in their usage followed as attitudes changed towards traditional smoking.
Product Awareness Following some hesitance, over time, the view of e-cigarettes within the UK changed and were viewed as an alternative to tobacco products as a cessation device.

In 2009 Action on Smoking and Health (ASH), a charity set up to eliminate the harm caused by tobacco, endorsed e-cigarettes as a means of a safer way of delivering nicotine to consumers, as they did not contain the same harmful components found in traditional tobacco cigarettes.
UK Market Growth By 2013 UK sales were estimated to be around £200 million1 with an estimated 29.3 million people throughout the EU reported to having used an e-cigarette2, however, the National Healthcare Service (NHS) reported that 19% of adults in Great Britain were still smokers3.

In 2014 Public Health England (PHE) stated that e-cigarettes were around 95% safer than smoking.
Market Regulation In October 2015, regulations were set to provide protection of young people against E-cigarettes, by introducing the prohibition to the sale of E-cigarettes to people under the age of 18.

In 2016, the EU revised the Tobacco Product Directive to included regulations for nicotine-containing electronic cigarettes and refill containers (EU TPD, Article 20).
Soon after the regulations were implemented, the EU saw that producers were actively complying with the new regulations with almost 100,000 products notified to the European Commission, 35,000 of the notifications being from the UK to date there are just over 43,000 products notified in the UK4.

The UK has seen roughly a 5% decrease in the number of smokers, as a report by the NHS5 concluded that 14.4% of adults are classified as current smokers (2018) compared to that 19% in 2013.
1 ‘UK market and regulatory report’ - ECigIntelligence 2 ‘Electronic cigarettes: a task force report’ - European Respiratory Society 3 ‘Statistics on Smoking, England 2015’ – NHS UK 4 ‘One year on: the picture is clearer as TPD reaches its anniversary’ - ECigIntelligence 5 ‘Statistics on Smoking, England 2019’ – NHS UK Tobacco Harm ReductionSubmission 169 Effects of current regulations in the UK The Tobacco Products Directive (TPD) is guidance set out for EU member states and covers the manufacture, sale and advertisement of tobacco and their related products.
An expansion of the TPD, Article 20, in 2016 led to the inclusion of guidelines for nicotine containing e-cigarettes and refill containers.

This update coincided with the UK introducing the Tobacco and Related Products Regulations 2016 (TRPR).

Whilst non-nicotine containing refill containers are regulated by general consumer laws, such as the General Product Safety Regulations 2005.

The collective requirements of these governing bodies are aimed to provide control measures in order to protect consumers.
Some of these are discussed: Requirements for electronic notification to each member state; All manufactures/producers of e-cigarette and refill containers must submit an online notification to each member state they wish to place their products on the market.

The notification should include the details set out in regulations, some of which are;         The name and full contact details of the manufacturer and importer of the product.
Full ingredient listings including toxicological data for each ingredient, including in heated form and the health effects when inhaled.

Testing of the emissions of the electronic device and e-liquid when used at reasonable conditions.

Testing and confirmation of consistent nicotine delivery form the e-liquid and device.

A description of the manufacturing process of the product.
A description of the components of the product including the use and opening and refill mechanism of both the E-cigarettes and refill containers.

A declaration from the manufacture or import that they bear full responsibility of the safety and quality of the products they place on the market.

Confirmation that only high purity ingredients have been used in manufacturing.

Requirements on the presentation of the products.

E-cigarettes are child proof and tamper proof.


  Must be manufactured using only high purity ingredients.

 Prohibited ingredients for the use in E-liquids, such as CMRs, Caffeine or other stimulant compounds and Vitamins or ingredients that suggest that E-liquids have health benefits.

The above list are the rules set out by the TPD.


The UK has expanded on this list and have listed further ingredients and chemicals which they have prohibited for the use in e-liquids, such as, Diacetyl, Pentane 2,3 dione, Acrolein, Formaldehyde.

Requirements for Labelling and packing.

       Packaging should not appeal to children.
Packaging should include the health warning “This product contains nicotine which is a highly addictive substance” which should cover at 30% of the immediate packaging.

A list of all ingredients contained in the product.

An indication of the nicotine content of the product.

Batch number A statement for the recommendation to keep the product out of reach of children.

Safety information such as adverse effects, toxicity and addictiveness.
Tobacco Harm ReductionSubmission 169 Vigilance requirements Further guidance is given that all manufactures should operate a process to record any adverse health effects reported by consumers regarding their products.

Once the report is received the manufacture should submit the findings to the appropriate member states, competent authority.

The competent authority for the UK is the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA already has a “yellow card scheme” which allows any persons to report suspected safety concerns of products notified.

This allows them to collect and monitor any reports of incidents or safety concerns and address them appropriately.

The MHRA have also comprised a database which is available on their website.

Here consumers who have purchase a product in the UK, can check that their product has been declared and adheres to the guidelines set.
Before these rulings were introduced, e-liquids were being manufactured under a variety of conditions.

Authorities have now ensured that manufacturers bear the responsibility of where and how e-cigarettes and refill containers are manufactured, helping safeguard each of the member states consumers.

Further regulations Although not a requirement, manufactures have recognised the importance of implementing in house controls and measures.
It has become an industry standard throughout the UK that companies have become ISO certified and work towards Good Manufacturing Practice (GMP) standards.

This includes the implementation of.

A full quality management system.

Full batch traceability.

- - - Quality Control checks and measures.

- - - Goods in and out testing.

Implementation of risk assessments, corrective and preventative action processes.

Customer complaints and conclusions monitoring.


There are many other regulations, that were already adapted in the UK, that e-cigarette and refill containers fall under such as.
CLP regulation EC No 1272/2008 Plugs and Socket (Safety) Regulations 1994 - - Weights & Measure (Packaged Goods) Regulations 2006 - - Waste Electronic and Electrical Equipment Regulations 2006 - - - Batteries and Accumulators regulations 2008 The control of Misleading Advertisements regulation 2000 Advertising Standards Agency Code The lack of regulatory framework in Australia, is exposing consumers to below standard products and potentially, nicotine poisoning.
Australia must move to implement a regulatory framework which takes into consideration quality assurance, onshore high-level manufacturing processes, and product/packaging requirements in order to safeguard the end consumer.

Tobacco Harm ReductionSubmission 169 Teen Vaping Although teen vaping has been considered an issue in other countries, through regulation, control and deployment of good public guidance, the UK have not seen this level of under 18s taking up vaping.
In a survey conducted by ASH in 2019, it was reported that “More than three quarters of 11-18 year olds have never tried (76.9%) or are unaware of e-cigarettes (6.6%)”6 in their conclusion it was found that while some teenagers (who are current smokers) have tried e-cigarettes, regular use of the devices is still very low.
Many other studies have also reported that teenagers are not seen to be using e-cigarettes in abundance, this is most likely due the regulated age of sale and ID verification process, age of sale restrictions and strict advertisement regulations set out by the UK – these measures should also be implemented in Australia to minimise youth uptake, along with large fines for retailers who break the law.
The backing of Public Health England and Cancer Research UK PHE soon aims for the England, to become a tobacco free generation.

They have recognised that one of the key ways to becoming a tobacco free generation is to offer current smokers, less harmful alternatives, that are supported by local Stop Smoking Services (SSS).

According to a survey in the Smoking Toolkit Study, it was concluded that the most popular quitting aid was an Electronic Cigarette7.
Professor John Britton’s 2014 review for PHE, stated “that while vaping may not be 100% safe, most of the chemicals causing smoking-related disease are absent and the chemicals present pose limited danger, remains valid.

The current best estimate is that e-cigarette use is around 95% less harmful to health than smoking” This was further backed by the charity Cancer Research UK, who in February 2017 funded a study to determine, if any, the positive impacts on former smokers after swapping to e-cigarettes.
The report, published in the Annals of Internal Medicine concluded “Cancer Research UK-funded scientists found that people who swapped smoking regular cigarettes for e-cigarettes or nicotine replacement therapy (NRT) for at least six months had much lower levels of toxic and cancer causing substances in their body than people who continued to use conventional cigarettes.” “[…] Dr Lion Shahab, senior lecturer in the department of epidemiology and public health at UCL [University College London], and lead author of the publication, said: ‘Our study adds to existing evidence showing that e-cigarettes and NRT are far safer than smoking, and suggests that there is a very low risk associated with their long-term use’.”8 6 ‘Use of e-cigarettes among young people in Great Britain’ – ASH.
7 ‘Electronic cigarette use for quitting smoking in England: 2015’ – Smoking Toolkit Study 8 ‘Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users’ - Annals of Internal Medicine Tobacco Harm ReductionSubmission 169 Infographic – cruk.org Further citations The Royal College of Physicians gave its position on e-cigarettes in a report made just before the implementation of the regulations, in which they stated.
“hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco” “There is a need for regulation to reduce direct and indirect adverse effects of e-cigarette use, but this regulation should not be allowed significantly to inhibit the development and use of harm-reduction products by smokers.”9 The UKs shadow secretary of state for health, Heidi Alexander, in 2015, stated in an email response that.
“I believe that recent research shows that some of the initial concerns about e-cigarettes were overstated.
Vaping can be a safe and effective way to give up smoking and I believe the government should be doing more to promote e-cigarettes as a potentially useful aid to help people quit smoking.” Martin Dockrell, who is leading the tobacco control programme for PHE stated in an interview conducted by the BBC, that the UK have one of the tightest regulations for e-cigarettes that stops short of banning them altogether.
This puts us in a very good balance between countries who have completely banned the products against countries who do not regulate the products at all.
He was also later reported to say “The consequence of this panic [about vaping] is that people will go back to smoking and die as a result,” 9 ‘Nicotine without smoke, tobacco harm reduction’ - Royal College of Physicians Tobacco Harm ReductionSubmission 169 It is of paramount importance that Australia regulates the E-cigarette industry utilising a common- sense approach in line with other developed countries for tobacco harm reduction.
See below graphs highlighting the effect of a regulated market with widely available nicotine containing E-cigarettes on smoking prevalence and vaping prevalence - this would not have been achievable with a restrictive prescription only model as is being proposed in Australia.

Tobacco Harm ReductionSubmission 169