Tag Archives: regulations

UK Becomes the First Country to Regulate CBD Market

The UK has recently become the first country to regulate orally consumed CBD products. Currently, CBD has been touted as a novel food group item or supplementary, but the new move to regulate CBD hopes to “de-risk” CBD (Cannabidiol) to spur innovation. With a clear set of guidelines for orally consumed CBD products, there is a growing likelihood of improvement in the sort of products offered.

In response to this move, the FSA (Food Standards Agency) and the ACI (Association for the Cannabinoid Industry) has created a list featuring CBD products. These products have been given the green light to remain on shelves in line with the UK’s new novel foods regulations. Products that do not appear on the list can no longer be sold.

Ensuring these guidelines are met by CBD products not only helps to ensure the quality and safety of products in England and Wales, but also for investors looking to take part in the CBD industry. Trading Standards will also be enforcing the new rules with immediate effect on retailers selling CBD products.

Regulating orally consumed CBD products

From February 13th, 2020, no new CBD extracts, isolates or associated final products using the novel ingredient CBD, are allowed to be sold until they receive the necessary authorisation. Products that were available beforehand were required to send an application for assessment by the FSA. The complete process of evaluation can take around a year to complete. One month is allowed for the validation process, then up to nine months for the risk assessment, and up to seven months for any subsequent risk management and authorisation decisions.

Most applicants will be manufacturers of CBD brands including us here at Xyfil. A detailed dossier must be provided for existing and new orally consumed CBD products.

There are three parts involved. Firstly, part one should contain all administrative data such as information relating to the applicant. Part two should contain information specific to the novel food (along with a list of references) such as:

  • identity of the novel food
  • production process
  • compositional data
  • specifications
  • the history of use of the novel food and/or its source
  • proposed uses and use level and anticipated intake
  • absorption, distribution, metabolism and excretion
  • nutritional information
  • toxicological information and allergenicity

Part three should include the glossary or abbreviations of terms quoted in the dossier, certifications (on the accreditation of laboratories, certificates of analyses), full copies/reprints of all pertinent scientific data (published and unpublished), full study reports and scientific opinion of national/international regulatory bodies.

Ensuring the quality of the dossier, and the information provided significantly affects the time needed for assessment and authorisation.

Xyfil makes the process simpler for you

Brands can apply for authorisation of CBD extracts and isolates via our compliance and White Label service. We will guide you through the process and secure your products ready for sale. Here at Xyfil, we have worked on countless successful applications for CBD-based products. Our market-ready approach means less paperwork and less hassle in getting your business off the ground.

By working with us you can benefit from our purpose-built analytical laboratory, including patent-pending equipment for generating accurate emissions samples. Work with our dedicated scientists and let us handle your brand compliance from end to end. Get in touch today to get started on your CBD brand.

E-Liquid Brand Case Study: Drop E-Liquids

Who are Drop E-Liquids?

Drop E-Liquids offer a range of fantastical fruit flavour combos that create sweet and sharp, refreshing vapes. Fruit Drop aims to create authentic fruit flavours that vapers crave and create exciting fruit blends you can’t get anywhere else. They also include a range of candy-inspired flavours called Sweet Drop, focusing on classic British sweet flavours.

Fruit Drop boasts flavours such as Citrus Lychee Ice, Passion Fruit Mango & Pineapple and Grapefruit Blood Orange. There are even a couple of candy-inspired flavours as part of their Sweet Drop range from Drumstick to the classic Rhubarb & Custard.

This range of E-Liquids is offered as 100ml shortfills with a 70/30 (VG/PG) ratio that is ideal for Sub-Ohm vaping.

With a simplistic design, these E-Liquids can seem unassuming, but the minimalist approach works well in drawing the eye to their signature ‘drop’ design. Each drop features a distinct blend of colours that suggest the flavours of each bottle.

Who manufactures Fruit Drop?

Drop E-Liquids are manufactured here in the UK by Xyfil Ltd, a premium UK manufacturer of E-Liquid and CBD products. We work with Drop E-Liquids to provide the base ingredients for their chosen flavour profiles, to create unique blends you’ll find nowhere else. To make sure the flavours are authentic we only use premium food-grade ingredients sourced from the UK and overseas. Some brands choose a specific flavour blend to create a very specific type of profile, while others choose a flavour for us to recreate. We are able to work with as much or as little information towards a brand’s vision to help them create the product they wish to take to market.

All E-Liquids are mixed and bottled in our ISO 9001 accredited facilities which go through stringent checks to ensure the safety and quality of each batch. Throughout the process we work closely with Drop E-Liquids to make sure that flavours remain consistent, and that the brand’s image remains the same throughout the process. A premium brand means premium quality. In such a large market where flavours mean everything, coming up with new and unique blends is what sets brands apart. Ensuring that the flavour blends match up to a brand’s expectations is key.

Drop E-Liquids provide their own artwork for their shortfill bottles, which we apply during the production process. Some brands require us to design and create their ideal packaging and logos. Drop E-Liquids however already had a clear image of their intended packaging. Applying a brand’s existing artwork to the products we manufacture for them is but one part of the bespoke service we can provide.

From the ground up to the store shelf

Xyfil offers a bespoke manufacturing service for E-Liquids and CBD products, with a choice of white label or OEM (Original Equipment Manufacturer). No matter what step of the process your product is at, be it production, manufacturing, or development, Xyfil can help take your brand from paper to reality.

We work closely with our customers to ensure their vision becomes a reality whether it’s in flavour development, production, bottling, packaging, or any stage of the process. If you are looking for help with E-Liquid compliance and regulations, we are also able to provide this service by submitting compliance for you or guiding your brand on the right path.

If you’d like to work with us to manufacture your next premium E-Liquid brand, get in touch today to find out more.

Raids on Vape Stores in the UK – The Importance of Compliance

Recently, vape stores in the UK are seeing visits from Council and Police members in a surge to crackdown on illegal vape products. Up and down the country some vape stores are finding themselves missing thousands of pounds worth of goods. This is due to some vape stores selling products that are illegal by UK trading standards. Which has left a few store owners with fines to pay and lessons to be learnt.

Stores around the UK cleared of illegal vape products

Vaping has reached all-time high popularity in the UK with new products added to the market around the clock. Especially with the rise in disposable vape devices, the market has certainly seen an explosion of interest from brands looking to add their own disposables. To keep up with demand shelves are being heavily stocked with the products that consumers are looking for. But in the midst of the rush it’s easy for non-compliant products to slip through.

In the UK there have been numerous cases of vapers using illegal and sometimes counterfeit products. Not only is this harmful to customers but also to brands of counterfeited products, stores that sell them unknowingly and the vaping industry as a whole.

Only recently, a vape store on Oxford Street, Westminster, was cleared of £100,000 worth of items from their shelves. These counterfeit and illegal goods were removed by Met Police and Westminster City Council with a variety of these products pertaining to vapes. These were disposables that were counterfeit along with products not suitable for UK retail due to not meeting compliance requirements.

What are the legal requirements for selling in the UK?

If products are TPD/TRPR compliant there will be several key factors that you can easily look out for.

  • Disposables and vape kits will have a max capacity tank of 2ml.
  • The max strength nicotine allowed in the UK is 20mg/ml.
  • Packaging should include UK manufacturer’s contact details and name.
  • Packaging should include all necessary warnings.
  • Must be registered on the MHRA’s (Medicines and Healthcare Products Regulatory Agency) website.

For the full list of regulations, you can read the UKVIA’s (United Kingdom Vaping Industry Association) concise guide for compliant disposable vapes here.

How you can be careful when selling vape products

Avoiding illegal and counterfeit products means you avoid potential losses and fines. The biggest issue in the UK vaping market is certainly high strength vapes or those with bigger capacity than is legally allowed. If a product is more than 20mg/ml (2%) or has a capacity greater than 2ml, then it cannot be legally sold in the UK. Check out these top tips on how to sell vapes legally in the UK.

Restrictions and regulations across the globe differ meaning that it’s quite easy for higher strength vape products to exist legally. For example, for products in the UAE the max capacity of vape tanks is no more than 10ml. Although these are legal for sale in the UAE, they are not in the UK, and sometimes this confusion can lead to incorrect products being stocked on shelves.

Compliance made easy with Xyfil

Navigating compliance can be challenging with the many regulations and differences between countries. Here at Xyfil we have a dedicated compliance team that ensure our brands and the brands of our partners, are compliant with whatever market they wish to sell in. If you’re looking to create your own UK-compliant brand of E-Liquids and vape products, you can contact us to find out more, and make the most of our award-winning, premium products. If you’re looking to stock the products we manufacture, you can talk with our sister company My Vapery who can offer you premium, UK-compliant products that customers want.

Industry news – Danish Government Proposes Nicotine Ban

In a move that mirrors New Zealand’s prior shift in nicotine-containing products, Denmark is following in their steps. Recently, the Danish government have proposed a nicotine ban to anyone born in 2010 or after. No doubt in hopes of ensuring future generations remain nicotine-free.

The proposed bill is believed to help reduce the number of smokers, coming into effect in 2028 – when those born in 2010 turn 18. From then on, the legal age requirement for buying nicotine-containing products will increase each year. Importantly though, it is noted that they are not banning the use of nicotine-containing products, just the ability to buy them. So, what does this mean?

There are concerns that this style of strategy fails to consider tobacco harm reduction by limiting items such as E-Cigarettes and E-Liquid. Any vaping product that contains nicotine will also fall under this ruling and therefore manufacturers and brands need to be on the lookout.

Compliance labelling – Keep your vaping products compliant

These new market changes can happen quickly and sometimes before companies have a chance to react. Luckily this occurs less and less nowadays but changes to regulations do still occur. And these require brands and companies to rethink their strategies and their products.

Lately, there have been many countries that have started to lean towards banning flavours. This has resulted in brands having to limit their flavour lists or create whole new ranges to remain relevant. Similarly, the move towards changing the legal age for purchasing nicotine-containing items may require brands to change up their product warning labels each year, to mirror the changing age limit.

This could be quite costly for companies having to re-print/re-package their products each year. Or perhaps compliance guidelines for these countries may take on a new approach?

In our opinion, we believe it is possible that governments will change the legislation for product labelling for nicotine-containing products. Currently, to be TPD compliant, vape products that contain nicotine must have an ’18’ age restriction symbol on the packaging and labels. Thereby it could be very likely that a new symbol to signify age restriction is created and will become a requirement for products to be sold in affected countries. But at this moment in time, there have been no talks on the subject, possibly due to the legislation not yet coming into effect. We’ll keep you posted as soon as we know.

The ability to cope with market changes

At Xyfil we are actively on the alert for any market changes that could impact brands and help them manoeuvre the market. Whether it’s updates to regulations, changing flavour recipes, updating information on product labelling and more, we’re here to help.

Our in-house compliance team are dedicated to ensuring that your products meet the necessary requirements for the market you wish to target. And with our 10+ years of experience in manufacturing, R&D, production, flavour development, logistics and more, Xyfil are more than ready to help.

Keep in the know with the latest in the vaping industry with us at Xyfil. Check our info hub for more news.

Industry News – Lithuania Bans Flavoured E-Liquid

Lithuania becomes the next country to ban flavoured E-Liquids as part of a worrying trend we are starting to see. It becomes yet another country that has decided to ban flavours bar tobacco E-Liquids. A move that is highly questioned by vaping advocates.

They join the likes of the US, Finland, Ukraine, Estonia and Hungary who have also introduced flavour bans. Denmark and Netherlands are also looking to introduce the same ban.

Like many, they claim that by banning sales of flavoured E-Liquids, young adults are less likely to take up E-Cigarettes. A problematic opinion for many as flavoured E-Liquids have been shown to be a key factor for many vapers making the switch from smoking.

Why have they banned flavoured vapes?

The Lithuanian parliament, Seimas, have argued that sales of E-Cigarettes have been growing increasingly popular in Lithuania. By banning flavours other than tobacco they hope to stem the tide of sales, and potentially deter any possible young adults from taking up vaping. This ban will prohibit the production and sales of flavoured E-Liquid as of July 1st 2022, including those that don’t contain nicotine (shortfills).

There have been arguments that suggest Lithuania’s ban on flavours could potentially result in many vapers returning to cigarette smoking. Although Lithuania is one of Europe’s smallest countries with under 3 million residents, almost 30% of Lithuania’s adults smoke cigarettes giving them one of the highest smoking rates in the EU.

It’s important to note that Lithuania also ban the selling of E-Liquids or E-Cigarettes that contain vitamins or other additives, that create an impression that they are good or do less damage.

What does this mean for manufacturers and brands?

The ban in Lithuania means that E-Liquids (including non-nicotine shortfills) that contain flavours other than tobacco, will be banned in the country. Brands looking to remain on shelves in Lithuania will have to shift to tobacco flavoured E-Liquids or find an alternative around the ban.

At Xyfil we are actively on the alert for any market changes that could impact brands and help them manoeuvre the market. Whether it’s updates to regulations, changing flavour recipes, updating information on product labelling and more, we’re here to help. Our in-house compliance team are dedicated to ensuring that your products meet the necessary requirements for the market you wish to target. And with our 10+ years of experience in manufacturing, R&D, production, flavour development, logistics and more, Xyfil are more than ready to help.

Keep in the loop with changes to the industry, with Xyfil.

Compliance in the UAE – All you need to know

E-Cigarettes and E-Liquids only became legal for selling in the UAE as of April 2019. Up until that point sales of electronic nicotine delivery systems (ENDS) were illegal. ESMA (Emirates Authority for Standardization & Metrology) standards were introduced to regulate all nicotine-containing components used in E-Cigarettes, refill packages, E-Liquids and tobacco products. In the UAE, all products must go through the MoIAT (Ministry of Industry and Advanced Technology) before being sold on the market.

If you are looking to sell in the UAE and middle east market, there are many regulations to consider, all of which we can help you with.

What are the ESMA regulations?

Many of the regulations are similar to that of the UK and EU. The law regulates the safety of all components as both electrical equipment and containing hazardous substances. These regulations are in place to establish the utmost safety and quality of all E-Cigarette and E-Liquid products in the UAE.

There are many factors that are restricted due to the regulations that impact the design of products to be sold in the UAE, the manufacture and marketing of said products. These include:

  • maximum nicotine concentration is capped at 20mg/ml
  • maximum tank capacity is no more than 10ml
  • maximum capacity of refill packages is no more than 50ml
  • must display all health warnings in Arabic and English stating: “Contains nicotine which causes severe addiction, increased heart rate and high blood pressure. Nicotine is harmful to the health of pregnant and nursing women, and people suffering from chronic pulmonary diseases such as asthma and pulmonary embolism.” This must cover at least 50% of the main display area. English to appear on the lower front, Arabic on the lower back.
  • must also display a health warning in Arabic and English: “This product may pose a health hazard when inhaled, swallowed or gets in contact with the skin.”
  • must not contain a variety of harmful ingredients & additives including cinnamic compounds

What you need to know before manufacture/import

Before any E-Cigarettes or E-Liquids can be imported, manufactured or placed on the market, all products must be approved by the ESMA documentation. These satisfy the needs for:

  • reports of safety tests
  • list of full ingredients and quantities including statement specifying reason for including each ingredient
  • results of toxicology reports
  • data on nicotine doses and absorption
  • acknowledgement of manufacture/importer responsibility for quality and safety
  • descriptions for use
  • ISO 9001 certification for the manufacturing site
  • stability studies supporting product’s shelf life
  • lab reports including information on nicotine concentration, quality & safety, post-marketing and post-consumption analyses and electrical safety
  • risk assessment studies

Each item, whether E-Liquid or E-Cigarette, requires ECAS certification to ensure all of these needs are met. This is not only a lengthy process but can be quite costly to navigate with several stages for each certification and complete the appropriate paperwork. This is where Xyfil comes in.


How we can help you hit the Middle East market

“Our in-house team of compliance experts are able to perform the necessary toxicology tests and full reports required by ESMA. More critically, we are able to gather all necessary data into the format required by the MoIAT. With popular brands we manufacture like Pod Salt fast becoming one of the most popular brands in the UAE, we’re here to help bring even more premium brands to the Middle East.”

Pradip, Compliance, Xyfil.

Since the changes in 2019 that allowed for the selling of E-Cigarettes and E-Liquids in the UAE, we have been successfully manufacturing and selling products in the Middle East. With a valid UAE Industry/Trade License, we are licensed to manufacture products for UAE within the UK.

Currently, we are looking at establishing on-the-ground manufacturing facilities within the UAE to further increase our productivity. Demand for E-Liquids in the Middle East has only continued to grow and we are there to keep up with the demand. If you are looking to take your brand to the UAE, get in contact with us to see how we can help you.

As a Toll Manufacturer with ISO 9001 accreditation, we are skilled with over 10 years of experience in manufacturing, production, R&D, logistics, compliance and more. Whether you are looking to take an existing product and turn it into one for sale within the UAE, or looking to manufacture a whole new product range, we at Xyfil can help you through any and all stages.

Get to know us more and meet the team over on LinkedIn.

Flavor Development

Flavour Development – E-Liquid and CBD

E-liquid and CBD product sales margins don’t look to be slowing down anytime soon. In fact, some sources predict they’re set to climb by at least 20% between now and 2027. Now is the perfect time to get ahead of the curve.

Here at Xyfil we are experts in helping you develop your CBD or E-Liquid product, from initial idea development right through to creation, regulation compliance, and packaging design. The market for E-Liquids is competitive with new brands/products appearing every day. To stand out in this growing market and get ahead you must get creative when developing your next product flavour. 

Define Your E-Liquid with Flavour

With so much competition now on the market, offering something that’s new but has the staying power to build a loyal fanbase is key. Your product packaging and logo may be enticing to new customers, but what really keeps them coming back is the experience of a great product. Flavours are obviously a big factor in a customer’s choice when picking their E-Liquid or CBD vape. So whether you are looking to bring a new variation to an existing, popular flavour, or a completely new experience, research is key. Much research has found that fruit flavours rank highly amongst most vapers, albeit only by a little more. This doesn’t mean that other flavours such as menthol, desserts, drinks and tobacco should be ignored, it means there’s room for improvement which very well could be your next venture!

Let us lead you through the best route for flavour development. 

Eliquid

E-Liquid Essentials: Safety Regulations 

First things first, ensure your flavour producers are safe, regulated, and reliable. Not only is this an essential for sale in store or online across the UK and European Union, it ensures safety and consistency in your product, and builds trust in your customer base. 

Our  ISO 7 Laboratory testing at  Xyfil meets the highest standards of compliance, meeting full Tobacco Products Directive (TPD), toxicology and safety analysis requirements. Alongside stringent testing and safety measures and a dedicated, expert team of scientists, we maintain full traceability of all of our products. Throughout the production process, we closely monitor the quality and safety of our product, through employee traceability reports, raw material sample collections, and comprehensive recording of ingredients and product processes. 

Working with Xyfil means working with an industry leading team you can trust. When you’re trying to get ahead of the competition, make sure your production is as straightforward as possible and save yourself the stress. We’ve got you covered.

Creating A Bestselling Flavour 

Flavour development starts with focusing on your base taste. How are you going to create this, and what combination is key? Working with our dedicated team of flavour experts is central to developing a top selling CBD or E-Liquid product, with a flavour that sells.

Our flavour ranges are some of the broadest on the market - from apple and cherry menthol to blueberry ice, Cuban Crème and caramel latte. Our in-house research and development teams work consistently to explore and develop new flavour bases and combinations based on the latest scientific findings and insider market research. Whether you already know your exact flavour or have an idea on the taste you wish to create, Xyfil will help your dream become a reality.

Alongside a diverse and inspiring range of flavours to choose from, our cannabidiol is sustainably sourced from a premium, award-winning supplier. We also offer 100% organic CBD Isolate, full-spectrum CBD, MCT oil and flavoured terpenes as needed. 

How We Keep Your Flavour Safe

Confidentiality you can trust is essential to successful white label manufacturing. Setting your flavour, branding, and product marketing in stone will ensure your success over your competitors.  We’re proud to say our infrastructure, processes, and working systems are all centred around a secure protection of intellectual property and full confidentiality for all projects. Alongside compiling non-disclosure agreements (NDAs) as standard, we also include data masking measures such as advanced encryption and pseudonym systems. These methods ensure your product and specific flavour profiles are kept strictly between you and the dedicated project team in question. 

So, What Next? 

Drop us a message to get your product journey underway - it’s going to be a bestseller; we can already tell. 

TPD Compliance

What is TPD compliance and how can we help?

At Xyfil, we bulk manufacture E-Liquids, provide white label services and compliance, all to help you get from idea to reality. For many new business owners looking to join the E-Liquid market, compliance with the regulations surrounding manufacturing E-Liquids can be a hurdle. Here at Xyfil we can provide you with the peace of mind that your products have been tested and abide by the many regulations for selling within the UK and EU.

What is Compliance and why is it Important?

The Tobacco Products Directive (TPD) came into effect in May 2016 as the primary legislative framework for E-Liquid. Our in-house compliance and laboratory technicians will help ensure your products meet all TPD requirements, guaranteeing safety and quality standards. These UK and EU regulations include:

  • Restricting maximum volume of nicotine in a single container to 10ml
  • Restricting the capacity of tanks to no more than 2ml
  • Restricting the nicotine strength of E-Liquids to no more than 20mg/ml
  • The container must be child-resistant and tamper evident
  • The liquid must not contain caffeine, taurine or colourings
  • Submitting to the MHRA (for the UK & Northern Ireland) before being sold
  • Labels and packaging must include relevant warnings and information

In the UK, TPD compliance (Tobacco Products Directive) involves a lengthy process. Six months before the intended release of a new product, you must notify the government with all the information regarding the product, including a list of all ingredients and a sample for testing, or the documented results of testing. Some countries’ governing bodies send the invoice for this completely free, however in the UK there is a charge applied. Once the fee has been paid and the product ingredients and sample are deemed compliant, it is listed on the government website.

At this point, within the UK, the product can now be sold. Outside of the UK, the product can only be sold once the six months period has passed. If products are not TPD compliant, then they cannot be sold in the UK or EU markets. It’s important to note that in some countries such as Germany, Greece, and Netherlands, nicotine-free products like Shortfills and Longfills also require TPD compliance to be met before being sold to the public – in the UK nicotine-free products are sold normally without needing TPD compliance.

What we do for you regarding compliance

“We have completed compliance reviews for over 1000 products in the market. Our design teams will also help with compliancy on product labels & packaging. We’re here to help you along the entire process.”

Pradip, Compliance Manager, Xyfil.

Understanding the regulations, ascertaining correct samples or test results and documentation around the whole process, can be a daunting task for any business owner. However here at Xyfil we can do all the hard work for you.

With years of manufacturing expertise in securing regulatory approval in the UK and across international markets, we strive to provide a bespoke manufacturing service. Whether you have already done your own testing, have already listed your ingredients or are starting your journey with an idea looking to come to fruition, Xyfil has you covered. We have an experienced compliance and quality control team, and design studio team for working on your labels and product packaging.

We can handle the whole process from start to finish for you. We create an account with the government bodies in the countries where you wish to sell your product and submit a notification of the new upcoming product. Alternatively, some customers may already have an account and can simply provide us with access to submit on their behalf. From there we send a full list of flavour ingredients, of which can be provided by the customer or created by us by our expert flavour department and perform tests on a sample to prove TPD compliance. It is also possible for you to complete the sample test elsewhere and simply submit the results to us. For more information on the testing process, check out our previous article on TPD certification. We then send all this information to the governing bodies, pay the invoice where needed, and notify you once compliance has been agreed upon by the government and your product becomes listed on their website; for the UK this is the MHRA’s website. For other countries you can check here for the relative TPD regulations. At which point your product will now be able to be sold to the public and can be listed on your own website or in stores.

If you would like to speak with someone at Xyfil for more information or are interested in reaching out to us about your upcoming products, don’t hesitate to contact us here. Make the first step towards starting, refining and improving your business today.

E-Liquid Regulations

Everything You Need To Know About E-Liquid Regulation

Understanding E-Liquid Regulation As A Newcomer

Newcomers entering into the E-Liquid and vape market have a lot to get to grips with. Selling e-liquid products comes with various regulations and restrictions, depending on the country you’re selling in. It’s essential to be familiar with these rules and that your products are compliant in order to sell on the market. We know this can feel overwhelming to new producers – but don’t panic! This article will walk you through what you need to know to be prepared.

Who Governs E-Liquid Regulation?

Before you can get stuck into the details, you need to know the government and industry bodies you’re reporting to. The governing body in the UK for E-Liquid and nicotine vaping regulation is the Medicines & Healthcare products Regulatory Agency, or MHRA. This government agency is a division of the Department of Health and Social Care, and is responsible for the regulation and sale of medicines and medical devices. Compliance is an essential pre-requisite to UK sale.

What Are The Rules To Sell E-Liquid Products?

The MHRA originally outlined the standard regulations for selling E-Liquid and nicotine vaping products in the TPD or Tobacco Product Directive, a regulatory act for sale of E-Liquids within the European Union. Following the UK’s exit from the EU, regulations in Britain and Northern Ireland are now governed by the Tobacco Products and Nicotine Inhaling Products (Amendment) (UK Exit) Regulations 2020. It’s important to be familiar with the amendment act as well as the broader European regulations to ensure your compliance meets all requirements for the areas you wish to sell in.

Whilst regulations have changed and developed over recent years, they have followed the same pattern, with requirements for minimum safety checks as an industry standard for e-cigarettes, refill containers and E-Liquids, comprehensive product information to be shared with customers, and proactive efforts to prevent children from using E-Liquid and CBD E-Liquid products.

TPD Compliance

Specific requirements for E-Liquid producers demand:

  • Producers must limit e-cigarette tank capacity to 2ml
  • E-Liquids containing nicotine may not be sold in containers larger than 10ml
  • Nicotine strength must be no higher than 20mg/ml in E-Liquids
  • All packaging must be child resistant and tamper evident
  • A number of ingredients are prohibited, including caffeine and taurine
  • Clear labelling including health warnings are including on all products

EU Common Entry Gate

To ensure new E-Liquid producers are complying with all regulations appropriately, producers are required to submit their product date to the authorities for approval if looking to sell in the EU. This is done via an online platform called the EU Common Entry Gate, or EU-CEG.

Submission here must include:

A full product ingredient list

  • Emissions produced by your product – you'll would need to have these independently verified
  • Product nicotine dosage
  • Toxicological data
  • A description of your manufacturing process
  • Compliance declaration

Getting Started In The E-Liquid Market

These are the basics of E-Liquid compliance regulations for sale in the UK and European Union as of 2021. We know these will be a good starting point for you – at Xyfil we pride ourselves on maintaining the highest industry standard, and we’re on hand to help you with every stage of your E-Liquid production journey.

It’s always daunting starting a new business venture. We’ve been there and we know the pitfalls. Familiarity and confidence in these regulations will give you a solid grounding to get your first E-Liquid products approved and onto the market. And then, the sky’s the limit!

How To Launch Your E-Liquid Brand in 2021.

Getting To Grips With The Market

In the 5 years between 2014 and 2019, e-cigarette sales rose by $12.3billion, and estimates suggest the current number of adults who vape could be around 55 million. With the industry growing quicker than ever before, there has never been a better time to launch your e-cigarette brand on the vape market. As a leading CBD and E-liquid manufacturer with clients worldwide, we know better than most the challenges faced by new producers breaking into the market. Let us talk you through the launch process.

Gaining Legal Recognition

So, you’ve worked with a top team of producers, manufacturers and designers – maybe us! - to turn your product ideas into a tangible, ready-to-market product. Nice work. What next?  

As you might expect, there’s a good number of regulations you’ll need to be compliant with, along with gaining respective approvals, before you can sell on the market legally. In the UK, these are governed by the MHRA (Medicines & Healthcare products Regulatory Agency). 

The TRPR (Tobacco and Related Products Regulations Act) updated by the EU Exit Amendment 2020 is your main point of essential compliance, and producers must submit information about their products to the MHRA to ensure full compliance via the MHRA Submissions Portal and European Common Entry Gate (EU-CEG). Submission is recommended six months before you intend to put your product on the market for sale. Turnaround time from submission to receiving approval can take up to 60 days, and fees do apply. 

As producer, it is your responsibility to ensure your products comply with TRPR requirements. Once the MHRA are satisfied your product complies, it is recorded as “declared” and you are free to supply your product for public sale in the UK. Our compliance team can help with this process to make sure that everything is up to standards.

The Perfect Marketing Window

Receiving legal status is half the battle. Once you’re confident you can place your product on store shelves with ease, it could be all too easy to take your foot off the gas. But don’t stop here! This is the perfect opportunity to amp up your marketing campaign to increase your audience and generate your first sales. 

Make the most of your social media channels: post partnership content or discount codes for purchases through your new suppliers to direct traffic. Paid promotions across your platforms will also be a great opportunity to capture new potential customers who may not already be aware of your brand. Recent newcomers, JUUL, had excellent success with these techniques back in 2017 – their social media engagement rose from a monthly average of 765 in 2015 to 30,565 in 2017, and they managed to capture more than half of the entire e-cigarette market share by the end of 2017!

Time To Get Started!

Hopefully, our handy run down of launching an E-liquid brand on the market has given you a better understanding of how the process works. While it can seem overwhelming, being prepared and consulting the experts are some sure-fire ways to make your first product launch as smooth and seamless as possible. If you need help with any aspect of CBD production, marketing, or launch – why not drop us a line? Get in touch at info@xyfil.com.