Category Archives: Compliance

Why You Should Manufacture E-Liquids in the UK

We are one of the leading UK E-Liquid, personal care products and CBD manufacturers supporting brands worldwide as their businesses develop. At Xyfil, we provide end-to-end white label manufacturing services, helping you develop your brand from conception to reality. There are many reasons why manufacturing locally can benefit you when pushing your products into the market. Here are just a few of the reasons why your should manufacture in the UK, and how Xyfil can help with them.


Why manufacture in the UK?

The UK was one of the first countries in the world to introduce legislated E-Liquid product requirements and is still at the forefront in safety and quality. The UK’s regulations for safety and quality are often seen as examples of best practice and are implemented by other countries. By choosing to manufacture your products in the UK and with Xyfil, you are guaranteeing the exceptional quality and the safety of your products.

The UK and European TPD regulations are being carried ahead for other countries as the guidelines for manufacturing E-Liquids. That just shows how well-respected UK regulations are in the market.”

– Anisha, Operations Director, Xyfil

With ISO 9001 accreditation across our laboratory facilities, manufacturing processes and equipment, we at Xyfil continue to demonstrate the ability to provide products and services that meet customer and regulatory requirements. Since the initialising of the E-Liquid regulations and TPD compliance, we at Xyfil have been leading the way in safe product development. We were one of the first UK companies that registered successfully compliant products. Local manufacturing means that we can offer reassurance and security with your products. Manufacture local means you can visit the premises and communicate easily with our teams throughout the entire process.


British-made means quality

As previously mentioned, the UK’s regulations for the manufacture and selling of nicotine-based products naturally translates to a higher calibre of quality when it comes to British-made E-Liquids, personal care and CBD products. With Xyfil you can trust the quality of the products manufactured by us. With ISO 7 clean rooms that can produce 2.5 million E-Liquids, CBD products and Personal care products every month, not only can we boast quality but efficiency.

We also include batch code testing for complete traceability throughout the entire process. Not only are we able to trace the individual ingredients used, but also the specific packaging, the stages of manufacture and even each person that works with the product throughout the process. Ensuring quality is how we create award-winning products.


Local manufacturing to Global Distribution

man in warehouse signing off packages

Whether you are looking to sell solely in the UK, arguably one of the biggest vaping markets in the world, or across the seas, Xyfil can help you there. We are well connected in the industry with retailers and distributors across the UK, continental Europe, UAE, Middle East and USA. With an option of on-site warehouse storage for businesses with limited space, we can also offer logistical support to get your products where they need to be. With 10 years of experience under our belt, we can help manage your supply chain through drop-shipping to local retailers and customers across the UK and beyond.

It’s never been easier to reach a global market than it is with Xyfil. Not only this, but we are entirely flexible to changes in the market by offering bespoke services should things change. From changes in regulations that require packaging to be re-printed, we can offer our services to amend these labels, re-label and package your products and then have them distributed back into the market.


Why you should work with Xyfil for E-Liquid Manufacture

At Xyfil we provide support to brands as seen by the dedication to our white label services. Many manufacturers in the market began with their own brand of E-Liquids first before turning to help others get a step in the E-Liquid market; but we have been supporting independent brands since the very get-go, with systems in place that help support and build others.

An important consideration for anyone selecting a manufacturing partner should always be the risk management strategy of their manufacturing partners. The pandemic has taught the world many things about being able to assess and deal with issues caused by broken trade lines. Xyfil has a well thought out risk management strategy in place for every single component in our production and we operate a preferential UK supply chain policy in which we also evaluate the risk strategies of our own suppliers before engaging with them – we have back-ups for our back-ups!

During the pandemic, Brexit and supply shortages over the last two years, our strategies have been tested and proved through these rough seas without a single day of production lost.

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!

TPD - Regulations

What is TPD ?

If you’re looking at breaking into the CBD industry, you’ll have heard the term “TPD compliant” thrown around – but what does it mean? Let’s break it down for you. 

The Tobacco Product Directive (TPD) is a regulatory act in the European Union that sets restrictions upon the sale of tobacco products, including vaping devices and e-liquids. In the UK, this legislation is termed as the Tobacco and Related Products Regulations (TRPR), and was replaced by the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 following the UK exit from the European Union. 

The acts all follow a similar pattern in their regulations, and it’s essential to be familiar with these rules if you’re a CBD or vape product producer. You will not be permitted to sell your range commercially if you’re not compliant with these regulations, overseen in the UK by the Medicines and Healthcare products Regulatory Agency, or MHRA.

The TPD introduced rules which require:

  • Minimum standards to be met for quality and safety of e-cigarettes, refill containers and e-liquids
  • Information to be shared as needed with consumers to enable them to make informed decisions
  • Proactive efforts to protect children from use of these products

Their specific requirements mean producers must:

  • Cap e-cigarette tank capacity at 2ml
  • Cap the maximum volume of nicotine-containing e-liquid in a single container to 10ml
  • Cap nicotine strength in e-liquids at 20mg/ml
  • Ensure all packaging is child-resistant and tamper evident
  • Forbid certain ingredients and colourings, such as caffeine and taurine
  • Include clear warnings in product labelling

To ensure producers have met all of these requirements, all e-cigarette and e-liquid products must be presented to MHRA and approved by this body before they can be sold.

What Does TPD Mean for My CBD Brand?

Aside from being a mandatory essential for CBD e-liquid and vape sellers, being able to show compliance with regulations will be a great benefit for your sales. 

Proving that you have committed the time and effort to provide the safest product possible will be a huge reassurance to your customer base. These regulations also present a reliability and consistency in your CBD e-liquids which can win you customer loyalty over other brands.  TPD regulations set a standard for production and quality of CBD products, and presenting TPD certified products to the market will verify your brand as having the best working practices, and highest quality product.

How Does Xyfil Approach TPD Certification?

As market leaders, we’re always working hard at Xyfil to ensure we meet all regulations to the highest standard. Our facilities, equipment, and manufacturing processes are all ISO 9001 accredited, and our wide range of analytical solutions cover, among others, GC-MS and HPLC-UV screening and toxicological assessments. 

We also offer a side effects reporting portal directly through our website. This ensures our customers are always able to make contact as soon as possible should they experience any adverse effects, and we can respond as quickly as possible. Our position in the industry means we must respect the responsibility we have in terms of product safety and vigilance in reviewing physical effects. We’re proud to be trusted by customers and clients internationally, and intend to maintain our reputation through responsible regulation for years to come.

Work with Xyfil for TPD Accredited CBD Products

When you develop products with us, you can trust we will submit all elements to full testing to ensure comprehensive compliance as needed – and then keep everything hassle free by compiling reports and submitting to MHRA for approval. In everything we do, we work to exceed customer expectations for quality and safety, and take international regulations as our starting point. If you’re looking for a CBD and vape producer you can trust, get in touch with us today. Let us make your job easy, and take advantage of shelf-ready white-label CBD manufacturing with Xyfil.

E-cigarettes: regulations for consumer products by UK GOV

Guidance on how to get an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme and reporting problems with e-cigarette.

The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible for implementing the majority of provisions under Part 6 of the Tobacco and related Products Regulations (TRPR) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020.

The TRPR introduced rules which ensure:

  • minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
  • that information is provided to consumers so that they can make informed choices
  • an environment that protects children from starting to use these products.

The requirements:

  • restrict e-cigarette tanks to a capacity of no more than 2ml
  • restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml
  • restrict e-liquids to a nicotine strength of no more than 20mg/ml
  • require nicotine-containing products or their packaging to be child-resistant and tamper evident
  • ban certain ingredients including colourings, caffeine and taurine
  • include new labelling requirements and warnings
  • require all e-cigarettes and e-liquids be notified to the MHRA before they can be sold

The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 is available here:

An Explanatory Memorandum explains the changes from a policy perspective:

The 2020 regulations amend the Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019 to implement the obligations of the Withdrawal Agreement and the Northern Ireland Protocol in law. This amends the way in which the Tobacco and Related Products Regulations 2016 apply in Great Britain and Northern Ireland

The 2020 Regulations sets out the requirements for new products to be notified from 1 January 2021. This will mean that:

  • Producers placing products on the Northern Ireland market will be required to notify using the EU Common Entry Gate (EU-CEG) system for the notification of tobacco and e-cigarette products.
  • Producers placing products on the Great Britain market will be required to notify on the Great Britain domestic system.
  • Notifiers will be required to pay one fee if they notify in relation to placing products on one of the Great Britain or Northern Ireland markets and the same one fee if they notify in relation to placing products on the two markets.

Full documentation: Read https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products