• 01772 888 778
  • info@xyfil.com
  • Unit 1 & 2, Durton Lane Business Park, Preston, PR3 5LR

Category Archives: Compliance

Xyfil Ltd   →  Blog   →  Compliance
Author Hannah Rubery Categories Compliance, E-Liquid, Regulations Posted on

How Long Does It Take? Registering Vape Products in the UAE

Vaping is becoming increasingly popular in the United Arab Emirates (UAE). As a result, the Ministry of Industrial and Advanced Technology (MoIAT) implemented strict regulations to ensure quality control of all vaping products sold in UAE, formerly regulated by the Emirates Authority for Standardization and Metrology (ESMA).

In this article, you will learn about ESMA's guidelines on registering vape products. We will also briefly cover how they differ from the Tobacco Products Directive (TPD) guidelines in Europe. Additionally, we will discuss how we can help as an E-Liquid manufacturer, ensure your products are compliant with ESMA's standards and successfully register them for sale in the UAE.

UAE guidelines for vape products

The UAE guidelines for vaping products are more stringent than the regulations set forth in TPD. For instance, to ensure the safety and quality control of e-liquids and devices, all products must be registered with the MoIAT prior to being sold in UAE. This includes any new product launches or reformulations of existing products. Guidelines 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

The process of registering products for sale in UAE

For e-liquids, the registration process typically takes 6-8 weeks to complete, while devices take 10-12 weeks. During this time, manufacturers will be asked to provide detailed information and documents such as:

  • Product label and artwork
  • Product information sheet
  • Ingredients list
  • Test reports/certificates of analysis
  • Compliance statement

In addition, products will be tested to ensure they meet all necessary safety requirements and guidelines. Once you have received the MoIAT/ESMA certification for your products, you can begin selling your vaping products in the UAE. All MoIAT/ESMA products are subject to a 100% excise duty/tax.

It is important to register your vaping products with the MoIAT/ESMA before selling them in UAE, as failure to do so can result in severe penalties and fines. Furthermore, registering your products will help you to ensure that they meet the necessary safety criteria and standards set forth by the MoIAT/ESMA, thus ensuring that your customers are provided with the highest quality products.

How Xyfil can help with compliance and registration

Xyfil simplifies the ESMA product registration process by offering comprehensive services to help manufacturers comply with all regulations and register their products for sale in the UAE. Our team of experts is well-versed in both UAE and EU regulations for those looking to transition or register new products in the Middle East. We provide assistance every step of the way to get your E-Liquids onto the UAE market.

Author Hannah Rubery Categories Compliance, E-Liquid Posted on

What You Need to Know – Registering Vape Products in the UK

The UK has implemented a number of rules and regulations around the sale, distribution, and advertising of vaping products. It is important to understand these guidelines in order to ensure legal compliance with the Tobacco Products Directive (TPD). In this article, we will discuss the registration process that must be completed for new vape products in the UK. We will explain the timeline and requirements, as well as how Xyfil can help make the process easier for you.

A brief overview of TPD guidelines

The Tobacco Products Directive (TPD) is a set of regulations enforced by the EU and UK that are designed to promote public health. These guidelines cover the manufacture, sale, and advertising of vaping products. For example, for vape products to be legal in the UK, they must comply with a list of requirements such as:

  • Bottles of nicotine-containing E-Liquid must be no more than 10ml
  • Vape products should now surpass 20mg (2%) in strength
  • E-Cigarettes should not exceed 2ml in capacity
  • All the relevant health warnings should be applied to the packaging
  • Must be submitted to the MHRA for approval

The TPD requires that all new vape products must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before they can be sold in the UK. This includes any iterations of the product that have received substantial alterations, which must be treated as new products.

The timeline for registering - why it's important

The registration process can take up to 6 months and requires detailed information about the product, such as ingredients, packaging materials, emissions data, testing certificates, and a sample of the product. If the manufacturer has already submitted a Great Britain and Northern Ireland notification for that specific product, then you do not need to submit a duplicate notification. Similarly, if re-branded and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.

Once everything has been paid for and received by the MHRA, the product you are registering will become visible on the government website. This helps to notify retailers and consumers that your product is trusted and compliant. The only exception to this rule is nicotine-free products which do not require registering with the MHRA at this time.

Xyfil can help take a load off by registering for you

Completing the registration process can be time-consuming and difficult to navigate, but Xyfil specializes in helping businesses comply with the TPD. We can handle all certifications for you so you can get your products on the market as soon as possible. Our team of experts have years of experience and knowledge about the regulations surrounding vaping in the UK and beyond.

We provide comprehensive support throughout the entire process, from submitting your application to obtaining product certification. We will also keep you updated on the progress of your registration and provide advice and assistance where needed.

By working with Xyfil, you can rest assured that your products are compliant and legal in the eyes of the law. Not only will this help protect you from any potential legal issues, but it also helps to build trust and confidence with your customers.

Author Hannah Rubery Categories Compliance, E-Liquid, Manufacturing, Xyfil Updates Posted on

Good Manufacturing Practices for E-Liquid Manufacturers

Good Manufacturing Practices (GMP) is an important set of standards that all manufacturers must adhere to in order to ensure the safety and quality of their products. These standards are a way to ensure that only safe, high-quality products are produced and distributed in the market.

At Xyfil, we take great pride in our GMP certification, which is an indication of our commitment to product safety and quality. And this year we successfully completed our GMP audit with 0 non-conformities or opportunities to improve; a clear testament to our dedication to creating high-quality products for our customers. Our facilities, health & safety processes and manufacturing processes have been audited & certified as following international quality standards and guidelines.

To obtain this certification, we had to pass a rigorous audit process that covers all aspects of our production and manufacturing processes. These include limiting cross-contamination, high standard safety procedures, our hygiene policy & procedures, quality controls in place for our suppliers and the materials, containers etc we source with strict due diligence. GMP audits also check that as a manufacturer, we comply with regulatory requirements.

In terms of our facility, our documentation, personnel & equipment is of good quality and abide by legal and safety standards. The audit also covers ensuring our staff are adequately safe and trained, or that training is in place.

All of this to make certain that the products we produce are of the highest quality available.

The differences between GMP and ISO certification

GMP certification is a step beyond ISO certification. While both are important for product safety and quality assurance, there are some key differences between them.

ISO certification tests for quality processes to ensure that the raw materials & products meet certain standards of quality. On the other hand, GMP audits focus on the facility itself and its ability to create robust and high-quality products. It assesses the hygiene, controls in place for suppliers, staff training standards, documentation and equipment standards and more.

In simple terms, GMP audit is all about safety & quality as a facility while ISO certification is mainly focused on creating robust quality measures for materials, and goods in and off the line. While ISO is necessary for E-Liquid manufacturers, GMP certification is the only way to guarantee that products are safe and of high quality. GMP ensures a robust quality product is created in a robust facility.

Why it's important to have GMP certification

As mentioned before, GMP certification is not a requirement for E-Liquid manufacturers however we believe it should be. Having GMP certification shows customers and potential customers that you are serious about safety and quality, which is of paramount importance. Most E-Liquid manufacturers only get ISO certified but Xyfil is one of the very few who have gone the extra mile to be GMP certified also. The process is entirely voluntary but helps to show our dedication towards the quality of our processes and products.

Despite this, we believe it's important to be GMP certified as it helps to minimise any risk towards consumers. And therefore, minimise any risk of poor quality for the brands we manufacture & produce for.

At Xyfil, going the extra mile to obtain GMP certification is part of our commitment to our customers in providing them with safe and reliable, robust products. We are proud of our achievements in successfully completing this audit process. Our customers can rest assured that their products are in safe hands when they choose Xyfil.

Work with us and see for yourself the results of our certification - contact us or book a meeting today.

Author Hannah Rubery Categories Compliance, E-Liquid, Other, Xyfil Updates Posted on

Changes to Certification & Fees for Vape Products in the UAE

The vaping industry in the UAE is continuing to grow with a projected revenue of US$59.38 million in 2023 – that’s almost double from 2019 when vapes first became able to be legally sold in the UAE. The market is also expected to grow by 9.41% from 2023 to 2027.

Recently in the UAE, the MoIAT (previously vape products were regulated by ESMA) registration fee has changed, no doubt due to the surge in the vaping market.

Changes to UAE registration fee

To legally sell vaping products in the UAE, E-Liquids and devices must be registered for approval with the MoIAT (Ministry of Industry and Advanced Technology). Typically, this is a service that can be provided via agencies, but Xyfil also offers compliance services, whether you’ve manufactured with us or not.

Registering your product for sale in the UAE requires two separate fees:

1) Certificate issuing fee: (It must be paid to the MoIAT). These fees have been reduced from AED 5000 to AED 670 per application.

2) Document review fee: (It must be paid to the notified body). There has been no change on this and it is still AED 800 per application.

For a full breakdown regarding products, see below.

 OLDNEW
LABELAED 5,000AED 670
PRODUCT-LIQUIDAED 5,000AED 670
RoHSAED 1,000AED 1,000
PRODUCT-DEVICEAED 5,000AED 670

There have also been some changes with the registration process. Originally, a single application could include different variations of flavours; so, if you had an E-Liquid flavour in several strengths, you could register them all under one application. This has since been changed and a separate application must be submitted for each sku that has a barcode. Should you wish to register a multipack of the same flavour and nicotine strength, along with the single pack variation, this will require two separate applications.

How Xyfil can help you with registering compliant products in the UAE

“Our in-house team of compliance experts are able to perform the necessary toxicology tests and full reports required by MoIAT. 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 compliant products in the Middle East. With a valid UAE Industry/Trade License, we are licensed to manufacture products for UAE within the UK. This helps to ensure that our products benefit from the superior British standard for manufacturing E-Liquids.

As a Toll Manufacturer with ISO 9001 and GMP certification, 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 of compliance.

Talk to us and book a meeting today.

Author Hannah Rubery Categories Compliance, E-Liquid Posted on

New Certification – Philippines Vaping Regulations Update

Recently, the Philippines took the vaping industry by storm with the news of its progressive vaping laws. The updated legislation helped to cement vaping as a legal smoking cessation tool and new rules are being introduced to help ensure the safety and quality of vaping products in the Philippines.

Certification for vaping products in the Philippines

The Bureau of Philippine Standards (BPS), an agency part of the Department of Trade and Industry (DTI), has recently added E-Cigarettes to the list of consumer goods subject to mandatory certification.

The recent vape law which came into effect on August 13th, 2022, regulates the importation, manufacture, sale, packaging, distribution, use, and communication of E-Cigarettes or vapes. But under the DTI Order 22-06, Series of 2022, E-Cigarettes and E-Liquids as well as HTPs will be subject to mandatory certification from January 4th, 2024.

This certification process is hoped to ensure the quality of vaping products and prevent illicit trade.

What this means for those importing to the Philippines

With these changes, it means that products covered by the BPS Mandatory Product Certification Schemes will be required to bear the Philippine Standard (PS) mark or Import Commodity Clearance (ICC) sticker. This helps to identify whether the products have been certified to conform to the necessary quality standards.

This will cover both E-Cigarette devices and E-Liquid.

Before this deadline, importers to the Philippines can voluntarily opt for a Philippine Standard mark or Import Commodity Clearance. To ensure your products meet the criteria for importing into the Philippines, you can check the DTI for more information.

How Xyfil can help with compliance

As a leading E-Liquid manufacturer in the UK, we have over ten years of experience in manufacturing and producing high-quality products around the globe. We are able to tailor products to match vaping regulations for countless countries including the UK, EU, US, and Middle East. Not only can we manufacture E-Liquid products to the specifications you require, but our in-house compliance team also excels in ensuring your products meet the requirements for where you wish to sell.

We have helped countless brands take their products to markets across the globe by offering compliance services. Not only can we make your products to spec, but run the necessary laboratory tests and process products with the necessary government agencies on your behalf.

If you would like to see how we can help you with your E-Liquid brand or create a new range, contact us today.

Author Hannah Rubery Categories Compliance, E-Liquid, Regulations Posted on

Avoiding Confusion with Nicotine-Free Disposables Legality

Zero-nicotine disposables are growing in popularity, but some stores are worried to stock them.

Disposable vapes are a perfect first step for many vapers as they offer a convenient and simple way to vape. Recently, some brands have branched out into developing 0mg nicotine disposables which provide all the flavour but without nicotine. But there have been reports of retailers being hesitant about stocking these sorts of devices.

Local shops refusing to stock nicotine-free disposables – why the confusion?

It seems there’s been some confusion with nicotine-free vaping products as some stores in the UK show hesitancy with stocking them. BetterRetailing reported that stores were refusing 3,500 puff nicotine-free devices with tank capacities above 2ml. Not all zero-nicotine disposable vapes offer such a high puff count, but many are beginning to do so.

So, why the confusion? By now, most are aware of what is TPD compliant (the UK regulations for vaping products). When it comes to disposable devices, we know that the E-Liquid capacity should be no more than 2ml which means they are usually capped at 600 puffs (650 at a push). And with recent store raids tackling illicit vapes that are not TPD compliant, it’s not hard to see why some stores are turning away these 0mg devices.

However, TPD guidelines are restrictions for nicotine-containing products, and thereby nicotine-free devices are exempt from these rules. Much like how shortfill E-Liquids are exempt from the restrictions which is why they can be larger than 10ml (the max capacity for nicotine-containing E-Liquids). Nicotine-free disposable vapes, if they contain no nicotine whatsoever, are legal in the UK at higher puff counts and capacity.

You can find more information on compliance with disposable devices in the UKVIA's guide.

The pros and cons of zero nicotine disposables

Nicotine-free disposables are yet another part of a vaper’s quit-smoking journey. Although they won’t help with quitting tobacco at the beginning, many vapers find that over time, they lower their nicotine strength after vaping for some time.

Since nicotine is an addictive substance that many want eventually to also quit, 0mg vapes are the perfect solution for vapers at the last leg of their quitting journey. These types of devices allow vapers to enjoy their favourite flavours and vaping experience without the addictive nicotine.

Zero-nicotine devices also allow for a smoother vape due to a lesser throat hit with the absence of nicotine.

Why retailers should consider stocking 0mg devices

As we mentioned, zero nicotine vapes are perfectly legal in the UK, including those at higher puff counts and tank capacities – so long as it is confirmed they are 0mg. No nicotine disposables offer a final stepping stone for vapers to quit nicotine whilst still enjoying their favourite brand or flavours. Vapers who already vape at low nicotine strengths can opt to use these nicotine-free devices as a means of quitting nicotine.

They are also suitable for casual smokers who may not need the nicotine hit as much as heavy smokers, but still struggle to quit because of the habits created by smoking. As vaping mimics, the motions of smoking a cigarette, these sorts of devices could be of benefit to light/casual smokers to quit cigarettes.

Vape retailers who can cater to a smoker’s quitting journey from start to finish may see greater customer loyalty and retention.

White label and OEM zero-nicotine products

Here at Xyfil we produce and manufacture a variety of E-Liquids for brands that range from our award-winning Nicotine Salts to premium Freebase Nicotine, to nicotine shots and nicotine-free E-Liquids. Our quality formulas and flavours continue to win awards across the vaping industry and with our white label manufacture, you get access to our existing, premium combinations. And even better, you can request these as 0mg to create shortfills or your own zero-nicotine disposable devices.

Or speak with us about our OEM opportunities for creating a bespoke range of no-nicotine disposables. With full flexibility throughout the entire process, we can help you go from idea to shop floor. Contact us today to start on your next range.

Author Hannah Rubery Categories CBD, Compliance, E-Liquid Posted on

The EFSA Put on Hold Novel Food Approval for CBD

Last month a decision was made by the EFSA (European Food Standards Agency) to put a hold on approving CBD as a Novel Food. It was cited that there was not enough data yet on the safety of CBD, and gaps in the data about potential hazards related to CBD.

The European Commission considers CBD to be a Novel Food product but requested feedback from the EFSA to agree on its approval. However, the EFSA revealed that further evaluations needed to be completed to ensure safety for human consumption.

What is a Novel Food and why is it important?

A Novel Food is defined as a food product that has not been consumed to a significant degree by humans before 15th May 1997, when the regulation first came into force. These pertain to newly developed, innovative food produced using new technologies and production processes. To be listed as a Novel Food, the items must be:

  • Safe for consumers
  • Properly labelled, so as not to mislead consumers
  • If Novel Food is intended to replace another food, it must not differ in a way that the consumption of the Novel Food would be nutritionally disadvantageous for the consumer.

Is this classification important for CBD? In short, yes. Having some sort of regulation that can ensure CBD products are safe and are not misleading, is important for customers and brand reputation.

A hold on approval isn’t necessarily a bad thing

There are some who might think this hold on approval is a bad thing for CBD but actually, it can be seen as a positive. The EFSA has noted that there are gaps in the data, but they have not outright suggested CBD isn’t safe for human consumption. The move to put it on hold in the EU is possibly a sign that they are considering following in the UK’s footsteps and requesting more data to be established. In the UK, we have already made the move to list CBD as Novel Food products and despite the EFSA’s decisions, the UK won’t be pulling CBD products from shelves, as the UK FSA have already taken steps to begin establishing regulations.

In the UK many CBD products are listed on the FSA’s website, those of which are legally allowed to be sold. They are still awaiting further assessment but many of them are allowed to be sold on shelves in the meanwhile, as there have been no immediate concerns raised.

Regulations for CBD is not something manufacturers should fear, in fact establishing regulations for CBD can only help to weed out illicit CBD products. Those that don’t contain the amount of CBD they claim or use sub-par, potentially harmful CBD (or none at all!), can easily deter consumers from trying CBD as the results from these products will only ever be lesser. Ensuring that consumers only have access to good quality products is how we can continue to grow the CBD market.

Why you should think about joining the CBD market

Even with the question of regulatory compliance hanging in the air, now is a great time to get ahead and prep your next CBD launch. CBD continues to be popular in the UK and overseas, and regulations only help to ensure that quality products are those that hit the market. Here at Xyfil we continue to produce high-quality CBD products, products that are listed on the FSA’s website, which means quality and safety for consumers.

Let us help get you to market with our experience in product development, manufacture and production. Not only this but we can help get your products onto shelves with our compliance team and understanding of market trends.

Author Hannah Rubery Categories Compliance, E-Liquid, Manufacturing, Regulations Posted on

How to Bring Your Brand to the UK Market

Looking to expand and take your product elsewhere? Understanding the regulations for the country you wish to sell your vaping products, is essential as they differ around the globe. And it is certainly worth taking your product to other markets, especially if it’s already receiving great success elsewhere. Let’s briefly look at the different regulations that govern the three main territories, and how they might differ from those in the UK.

The regulations for other countries

If your products are already listed in these countries, then chances are you are already aware of the different regulations. Here’s a brief list of the key regulations across the EU, US and Middle East.

EU Regulations

  • Child-resistant & tamper-proof packaging
  • Must notify the appropriate regulatory body with ingredients in E-Liquids components in devices and refilling mechanisms of devices
  • Devices must be protected against breakage and leakage
  • It must be possible to refill devices without leakage
  • Devices must deliver a consistent dose of nicotine per puff
  • Capacity of tanks, pods and cartridges must be no more than 2ml
  • E-Liquids containing nicotine must be sold in volumes of 10ml or less
  • Nicotine strengths of E-Liquids must not exceed 20mg/ml
  • Legal age for vaping is set at 18 for most EU countries
  • E-Cigarettes and re-fill containers can’t be advertised or promoted, directly or in-directly

These TPD regulations guide the majority of EU countries in their handling of E-Cigarettes and vape products. However, there are some countries that have begun to implement flavour bans or ban vaping entirely. Find out more about EU regulations here.

US Regulations

  • Register your establishment and submit a list of products, labelling and advertisements
  • Submit data and pay user fees
  • Submit an ingredient listing
  • Apply to market a new tobacco product via one of three pathways
  • Submit quantities of harmful and potentially harmful constituents
  • Submit tobacco health documents
  • Submit a warning plan for smokeless tobacco
  • Include required warning statements on packages and advertisements
  • Submit a modified risk tobacco product (MRTP) application
  • Age-restricted for those under 21 years of age

It’s important to note that some states in the US have also implemented flavour bans. This means they only accept tobacco-flavoured vapes and E-Liquids. Some of the regulations differ between states with some outright banning vaping altogether.

UAE & Middle East Regulations

  • 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 that 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
  • Prohibited to those under the age of 18

Some of these regulations can differ depending on the country as some Middle Eastern countries have outright banned vaping.

Many of these share similar restrictions with the main ones to take note of, are the limitations on size, strength, and ingredients, as these have an impact on the product you manufacture. Products that do not abide by the regulations of the country for reselling, will be classified as illegal and could be disposed of by authorities. Find out more about UAE regulations here.

Regulations for the UK

When bringing your brand and established products to the UK, you need to take into account the regulations established by TRPR (Tobacco and Related Products Regulations).

  • E-Liquid bottles that contain nicotine can be no larger than 10ml
  • Tanks, pods and cartridges can be no larger than 2ml
  • The maximum nicotine strength allowed is 20mg/ml (2%)
  • E-Liquids must not contain any ingredients that are disallowed
  • E-Cigarette packages must include an information leaflet
  • Packaging must include nicotine warnings on the front and back, covering 30% of the size

These regulations are very similar to the EU regulations with only small differences, but it’s important to make sure that your E-Liquid products match the specified strengths, max capacity, and warnings. Find out more about UK regulations here.

It is also worth noting that in the UK, advertising E-Cigarettes and vaping products is strictly regulated with only a few exceptions. Similarly, vaping products are age-restricted for those under the age of 18 and it should be a brand’s interest to ensure their products do not appeal to those who are underage.

For those with brands that cross different countries with different regulations, it could become the norm to label vaping products with the country it is intended to be sold in. Products like ELUX vapes have now begun including a ‘not for sale in the UK’ to their packaging for products intended for US markets. This is intended to help retailers from accidentally stocking products not legal in their country.

How Xyfil can help get you into the UK market

As a leading British E-Liquid Manufacturer, we have over ten years of experience in manufacturing and the production of E-Liquids suitable worldwide. We have helped hundreds of brands to market in the EU, UK and Middle East and more. Between our in-house compliance team and highly experienced members in all departments, we ensure that the products you want are suitable for the market you wish to hit. Whether that’s from the ground up with our white label and OEM E-Liquid manufacture, or with your pre-produced E-Liquids, we cover it all.

Xyfil is equipped to bottle your products in compliant bottling solutions, and our creative teams are able to create/edit product packaging to suit your needs. We offer many white label products which are already created and compliant for EU, UK and the Middle East to help you hit markets quicker. Or alternatively, if you’re looking to alter your existing products to suit new markets, we are more than equipped to handle any changes in product capacity, testing, packaging and more.

Contact us today to find out more about how we can help you.

Author Hannah Rubery Categories CBD, Compliance, Manufacturing Posted on

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.

Author Hannah Rubery Categories Compliance, E-Liquid Posted on

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.

1 2 3 4 5