As of May 20th 2016, all tobacco and related products must be fully compliant with the Tobacco Product Directive (TPD), before they can be sold within the EU. But did you know vaping equipment and e-liquids must also comply with the guidelines laid out in the act? Since the act has come into effect, all retailers, manufacturers and consumers must adhere to the policy. So, what is TPD compliant and how will you know if your e-juice is breaking the rules?
Table of Contents
What is TPD?
Before we delve into answering “what is TPD compliant?”, here is a brief overview of Tobacco Products Directive legislation and why it is needed.
In recent years, smoking has drastically changed. Although traditional methods like roll-ups and pre-rolled cigarettes are still popular, many people are turning to more modern ways of smoking i.e. e-cigarettes and vapes.
As the market changes, so do our scientific understanding of how these new products work, and how they affect our bodies. Therefore, legislation surrounding these products needed to be updated too.
TPD compliance is a legal requirement but specifications will differ depending on the type of product that you are manufacturing or retailing. For example, e-liquids that do not contain nicotine are not subject to compliance.
Devices, on the other hand, must comply with regulations, regardless of whether they are used for nicotine-infused substances or not. However, you do not need to report all of the specifications of the device, only relevant details like the tank capacity needs to be notified.
The main aims of the TPD act are to provide a uniform and up to date regulatory framework across the EU. The main aims of this framework are to:
- Ensure that all vapes, e-cigarettes, and e-liquids meet current health, safety, and marketing requirements. This will make them as safe as possible for users.
- Prevent manufacturers from using marketing or ingredients that will encourage non-smokers, or younger members of society, to take up smoking.
- Ensuring manufacturers and retailers provide customers with the appropriate information on product packaging.
- Prevent illegal trade and sale of tobacco and related products by using a track and trace system.
The main aspects of what is TPD compliant
The TPD Act includes detailed guidelines for many aspects of the sale of tobacco and tobacco-related products – all of which must be adhered to, to be fully compliant with the law. Some of the key aspects, included in the legislation include:
- Registration with the Medicine and Healthcare Products Regulatory Agency (MHRA).
- Product Restrictions.
- Packaging and Labelling Requirements.
- Restricted Advertising.
- Vigilance.
- Annual Sales Reporting.
Registration with MHRA is the first port of call
When discussing “what is TPD compliant?”, one must first consider registration with the MHRA and the European Commission. All tobacco and related products must be registered with the Medicine and Healthcare Products Regulatory Agency at least 6 months prior to being sold or distributed. This includes all vaping equipment, herbal smoking products, nicotine-free smoking products, e-liquids, and tobacco products.
Whether you’re manufacturing or importing these products, you must register with the MHRA, using the MHRA Submission Portal. You must also register via the EU Common Entry Gate (EU-CEG). This is an IT tool designed to collect information about the products that you are manufacturing/distributing. This information must be submitted to the authorities in the Member States that you’re planning on selling your products in.
To complete registration, you will need to provide the MHRA with information about the formulation and toxicology of the product, along with other characteristics such as emissions.
What are the packaging and labelling requirements?
As one of the main aims of this framework is to discourage non-smokers and younger members of society from taking up smoking, there is no surprise that there are strict regulations for the packaging and labelling of all products.
So, what is TPD compliant, when it comes to labelling? Each product must contain a clear safety warning. “This product contains nicotine which is a highly addictive substance” must be printed on the front and back of the product, covering at least 30% of the packaging.
Bottles of e-liquids are subject to rigorous limitations too. Each bottle must be child-resistant and unbreakable. Each bottle cannot expel more than 20 drops per minutes and the nozzle must measure at least 9 mm.
Are there limitations on product sizes?
When it comes to what is TPD compliant, there are stringent product restrictions. For example, one must ensure that all vaping equipment has an e-liquid capacity of less than 2 ml. Similarly, containers of e-liquid (containing nicotine) cannot exceed 10 ml per bottle. Nicotine-infused e-liquids are also limited in strength – one must not contain more than 20 mg/ml of nicotine.
TPD compliance also includes restrictions on other non-nicotine ingredients. For example, e-liquids cannot contain certain colourings or additives, such as taurine or caffeine. This list is non-exhaustive and other ingredients can be added to the list by the Member States if they are deemed unsafe for consumption.
All products must be tested in a certified laboratory to determine the emissions of each product, along with the ingredients and formulation.
Goods must be marketed responsibly
As aforementioned, one of the key aims of the legislation is to prevent non-smokers from taking up smoking. Therefore, there are strict restraints in place when it comes to advertising.
What is TPD compliant when it comes to advertising tobacco and related products? One can advertise products freely at multi-vendor sales events/ trade shows or in trade publications, such as magazines.
One can also advertise products by providing potential customers with factually accurate information. This includes blogs, social media posts, non-paid reviews, and tutorial videos/articles. Posters, billboards and leaflets are also permitted.
It is worth noting that in the UK only non-nicotine products can be advertised. This includes non-nicotine disposable e-cigarettes, non-nicotine e-liquids, non-nicotine disposable devices, and vaping or smoking equipment that only holds non-nicotine products.
What is not allowed when it comes to TPD compliance? According to current legislation, you cannot advertise on the TV, radio, or on-demand streaming/TV services.
Newspaper, magazine and online advertisements are also off-limits. Nor are you permitted to use product placement or social media marketing. Outbound or “push” marketing campaigns, such as cold calls or email marketing, are also prohibited.
Committee of Advertising Practice (CAP) Section 22
According to CAP, manufacturers and distributors need to carefully follow the guidelines that are in place, when it comes to advertising in compliance with TPD laws. As detailed in section 22, adverts must:
- Not make health or safety claims.
- Not make misleading claims about goods.
- Not include nor target children i.e. contain content that specifically appeals to children.
- Be socially responsible.
Vigilance systems
As required by the MHRA and the UK Department of Health, each manufacturer/distributor must have an adequate vigilance system in place. What is TPD compliant when it comes to your Vigilance system? This is a system to record, assess, and report safety issues of marketing goods.
According to article 20 (9) of the TPD document, each Member State of the EU must ensure that all importers, manufacturers, and retailers have an effective system in place whereby they can collect and report information adverse or side effects of vaping. One must also immediately inform the relevant authorities if any product is found to pose a risk to public health.
Firstly, one must appoint a vigilance person. This person needs to take on the responsibility of informing the authorities should something change in regard to the safety of a product. This person is also responsible for collecting and reporting information regarding potential adverse effects of products.
Each Vigilance system should be documented in detail and regularly updated as it can be subject to inspection by Trading Standards or the MRHA. Additionally, each product should be regularly reviewed and any developing or potential health concerns should be noted.
Annual sales reporting: Article 20.7
Another key aspect to consider when answering the question of “what is TPD compliant?” is annual sales reporting. According to the TPD guidelines, vape manufacturers and distributors must compile and provide an annual sales report to the relevant authorities.
Each report must include information regarding the sales in the previous year. Although the content guidelines for these reports differ slightly depending on the products, there are some main points that need to be included:
- Market surveys: You must include the findings from any market research conducted by your company.
- Customer demographics: Who is your typical customer? E.g. have they moved from smoking traditional tobacco products to vaping non-nicotine products?
- Sales information: You must provide a summarised sales report which includes how many units were sold in the previous year.
- Method of sale: One must detail how each product is sold e.g. do you sell exclusively via your website or are your products sold in brick and mortar stores?
You do not need to include all of your products in these sales reports, just products that have been registered with the EU-CEG/MHRA portals. You can easily submit these reports via the EU-CEG portal, or some Member States give the option of sending them via email.
In the UK, you can use the portal but you are also required to send an accompanying email copy too. This will differ from country to country though.
Penalties for late or non-submission of reports differ. It will depend on the Member State and the type of products that you manufacture/retail.
Why do authorities need information about vaping products?
As aforementioned, all of this information is required to stamp out the illegal trade of tobacco and tobacco-related products. Equally, it is also required to find out whether vaping can lead to nicotine addiction in non-smokers or the younger members of society.
Some studies, such as this one, suggest that vaping may have a “gateway effect”, making users more likely to develop a nicotine addiction over time. Researchers found that certain aspects of vaping, such as convenience, price and flavour, can be more attractive to younger audiences. Experts believe the increased acceptance and familiarity of smoking and nicotine consumption could potentially lead to a transition to smoking tobacco.
Are there penalties for non-compliance?
It is extremely important to note what is TPD compliant, to avoid penalties for non-compliance. In the UK, businesses can be penalized for a range of offences, including, but not limited to:
- Failure to adhere to instructions outlined by the TPD
- Failure to register products
- Failure to take corrective action to ensure compliance
- Failure to develop and maintain an adequate Vigilance system
- Failure to report adverse effects or safety concerns of products
- Failure to provide the required documentation and information to Member State authorities
The penalties for non-compliance differ in severity but in the UK, if one is found guilty of an offence, you may be facing 2-year imprisonment (maximum), a hefty fine, or both.
However, generally speaking, if you are in breach of legislation you will be issued a warning. If corrective actions are taken in a timely manner, to ensure all products and procedures are compliant, it is unlikely that one will face severe penalties.
What is TPD compliant, but is not required by law?
Although the TPD details stringent requirements for compliance, there are some things that are not a strict requirement. So, what is TPD compliant, but not a requirement?
Lab testing at MHRA/FDA approved labs
All products need to be tested by reputable laboratories, however, you do not need to opt for an “approved lab” for this. Ideally, you should choose a third-party testing facility that is not involved in the vape industry, thus ensuring completely unbiased results and confidentiality.
It is also worth noting that if you’re marketing and selling products in the UK, you should opt for UK-based testing facilities. Each test will provide a report that will need to be understood by each agency in the EU. Therefore, it is wise to provide a report in English, as this is the common language used by all agencies. However, if you’re intending to market your products overseas, you should consider including a report in the native language of the region too.
TPD “certification”
When it comes to what is TPD compliant, you will not receive a TPD certificate nor will the products be “approved”. In the UK, for example, once the MHRA conducts their compliance assessments, it will declare compliance. This means that the onus is completely on the manufacturer/distributor to ensure TPD compliance.
Compliance checks will differ between the Member States as each agency has different procedures.
Nicotine per dose, for e-liquids
According to TDP guidelines, you must perform emissions tests for vaping devices – this will show how much nicotine is expelled per puff/dose. But this is not necessary for e-liquids. For vaping devices, you should always include the amount of nicotine per dose, on the packaging.
However, if you distribute nicotine-infused e-liquids in the UK, you can include this information on the bottle/packaging as this will be beneficial when working with Trading Standards.
E-liquid analysis by GC-MS screening
Gas chromatography-mass spectrometry (GC-MS) is a method of analysis whereby features of gas-chromatography and mass spectroscopy are used to discern substances in a test sample. Although this type of screening isn’t explicitly required by TPD, it will depend on your circumstances whether it would be beneficial to you.
Likewise, it’s not required that you use GC-MS testing to determine the formulation of the product. You simply need to know the ingredients in each product and their quantities.
What is TPD compliant when it comes to cross-border sales?
As we know, TPD regulations are intended as an umbrella framework for use across the Member States in the EU. Thus, the guidelines contain specific information and requirements for cross-border compliance.
For instance, according to the TPD, each Member State has the option of banning cross-border sales. For the Member States that allow this type of distribution, they must have a system in place to register retailers.
As the UK is currently allowing cross-border sales, you can sell tobacco and tobacco-related products in the UK, provided you are registered with the MHRA and the relevant authorities. Equally, if you are selling products in another country, you must register with the authorities of those Member States.
In some markets, you may not need to register if you are only selling within your own country, However, this will differ depending on your location.
What is TPD compliant: To sum things up
Whilst adhering to TPD regulations is a legal requirement throughout the EU Member States, the requirements will differ depending on the type of products that you’re manufacturing/distributing.
Adherence to TPD requirements doesn’t necessarily mean that products can be legally sold in the EU – each Member State reserves the right to ban products that they feel pose a potential threat to public health.
What is TPD compliant? It simply means that you have submitted the correct documentation to relevant authorities, your packaging and advertisements are in line with guidelines, and you maintain an effective Vigilance system.
The main aims of the TPD framework are to reduce the number of non-smokers and adolescents taking up smoking or vaping, with the aim of reducing nicotine addiction. It also aims to record and monitor potential health concerns associated with vaping and smoking.
Another aim of the framework is to prevent the illegal trade of tobacco and tobacco-related products by providing traceability of these products.
TPD compliance is required by law and it is advisable to avoid looking for TPD loopholes as non-compliance to legislation can be punishable by imprisonment. Alternatively, you may face hefty fines.
Although we covered the main aspects, you may require more information to answer your questions on what is TPD compliant? For more information on the registration process and the required information, you can visit the official European Commission EU-CEG page here. You can also find more information about making submissions to the MHRA Submission Portal here.
As a consumer, if you're worried about what is TPD compliant, when it comes to products you're buying, you should always source your products from reputable suppliers. For example, CBD Village provides a wide range of vape equipment, along with e-liquids. You should always purchase CBD products from trustworthy sources to ensure that products are compliant with regulations, and you're getting the best and safest CBD experience possible.
