Tag Archives: compliance

Ireland’s Proposed Vape Regulatory Changes

Upcoming Changes to Vape Regulations in the UK

Ireland's Further Restrictions

Conclusion

Pioneering a Smoke-Free Future in New Zealand by 2025

Why Smoke-free Matters

Public Health Impact

Economic Benefits

Setting a Global Example

How New Zealand is Aiming to Achieve Smoke-free Status

New Zealand's Vaping Regulations

International Implications

Conclusion

The Changing Landscape of Vaping in Australia Explained

Australia's Shifting Policies on Vaping

The January Ban on Disposable Vapes

Upcoming Updates to the Regulations

Vapes Available at Pharmacies

Restrictions on Sales at Other Retailers

Timeline for Implementation

Pending Legislative Approval

Future Enforcement

Penalties for Vaping Violations

Personal Use Exemptions

Retailer Penalties

Selling Vapes in Pharmacies

No Display Policy

Plain Packaging Requirements

Limited Flavour Options

Conclusion

Belgium Joins the Disposable Vape Ban List

The vaping industry is facing a significant environmental and regulatory shift as countries begin to reflect on the convenience of disposable vapes against their considerable waste and potential health risks.

The Controversy Surrounding Disposables

The meteoric rise of disposable vapes has been accompanied by controversy. On one hand, enthusiasts praise the convenience and reduced health risk when compared to traditional combustible tobacco. On the other, the industry's heavy reliance on plastics and fears of an 'addiction conveyor belt' to traditional smoking, particularly in youth, have been alarming to policymakers and environmentalists.

Environmental Concerns

One of the most pressing issues policymakers have been warning about with disposable vapes is the environmental impact. Landfills are increasingly burdened with single-use plastics, and vaping devices are no exception. The lithium-ion batteries and various metals and plastics that construct these devices pose a significant problem for waste management and have long-lasting implications for the environment.

Protection of Minors

The compact and often brightly-coloured design of disposable vapes is at the heart of another concern – their appeal to minors. While there has been much debate on the topic, governments have been quick to pin the rise of under-age vaping on disposable vapes. The ease with which these products can be concealed and handled triggers fears of a new generation addicted to nicotine.

Belgium's Ban and Its Implications

Joining the fold of nations seeking to address these concerns, Belgium has pledged to ban disposable vape products. This prohibition is set to cover both nicotine and nicotine-free variants, making it one of the most comprehensive bans yet seen in this domain. The Belgian government, reflecting public sentiment and health concerns, is expected to publish the ban legislation around May to June 2024, with a tentative start date of January 1st, 2025.

The Ban's Scope

The prohibition will affect a broad range of disposable devices, including popular brands that currently dominate the market. The decision to include nicotine-free products is an important distinction, signalling that this ban is as much about health as it is about the environment. For Belgium, this decision could provoke change on multiple fronts, catalysing infrastructure for and consumer confidence around more sustainable alternatives.

Industry Response

Brands and manufacturers are scrambling to reassess their product lines in response to these bans. The shift away from disposables will necessitate a pivot toward more sustainable and reusable options such as rechargeable kits and E-Liquid refills. The Belgian market, as a result, is poised for a transformation that requires agile and forward-thinking leadership from industry stakeholders.

Retailer Resilience

Vape retailers play a critical role in the market, acting as gatekeepers to consumers. They will need to rapidly adjust their inventory, information management, and even staff training to accommodate the transition toward non-disposable products. This implies significant investment and rethinking of business models for some who only deal in disposable products.

Preparing for a World without Disposable Vapes

The upcoming ban in Belgium is not an isolated incident. Countries around the world are wrestling with the same issues, and similar legislation is anticipated elsewhere. For the vaping industry, this is a compelling signal to anticipate and prepare for change.

Innovating Away from Disposables

The ban on disposable vapes creates an innovation opportunity for companies within the vaping sector. By now, it's clear that the old 'take, dispose-of, and repeat' model is untenable. Thus, there's room for innovators to step up and find new formats and materials that don't contribute to environmental problems and provide even more benefits to customers.

Navigating New Regulations

Regulatory changes can be overwhelming, particularly for smaller players in the market. Staying informed and engaged with the policymaking process is crucial. This ensures that when new regulations are introduced, businesses are not caught off-guard and can pivot strategically. Working with reputable manufacturers like us here at Xyfil, who work in tandem with brands across the globe, can help ease the burden of regulatory changes and make fast, efficient changes to keep your brand afloat.

Educating the Public

With the inevitable shift away from disposables, there's a responsibility to educate consumers about the changes and the reasons behind them. The public needs to become aware of the solutions that the industry is providing, and educate why these are essential, to help avoid a potential black market situation.

The Role of Sustainability

Sustainability is becoming a key differentiator in the market. Consumers are increasingly seeking out brands and products that align with their values, and this is true in the vaping industry as well. Companies that lead the charge in sustainability stand to benefit from a positive image and potentially, new market opportunities.

Conclusion

Belgium's move to ban disposable vapes is a clear sign of a broader shift happening within the vaping industry. While they are not the first they will unlikely be the last. Perhaps it's time to make changes to combat these regulatory shake-ups, rather than trying to cling to what was before.

For brand owners and vape retailers, the proactive response to these changes will be pivotal – ensuring not just compliance but also market relevance and growth in a landscape that is rapidly transforming. The disposable vape ban is more than a regulatory issue; it's a call to redefine the essence of the vaping experience, integrating it with the values of personal and environmental health, as well as the long-term sustainability of the industry.

Recent MHRA Updates You Need to Know About

In a bid to tighten regulations and ensure public safety, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has made a wave of updates that directly impact the vaping industry. For vape brand owners, keeping a finger on the pulse of these changes is not just advisable—it's imperative to remain compliant and protect the integrity of your business.

This detailed blog unpacks the recent updates and highlights why awareness is your best defence against regulatory infractions.

The Disposable Ban Looms

The phasing out of disposable e-cigarettes in the UK is one of the most significant changes on the horizon. While official legislation is pending, the intent is to ban these products with a 6 month grace period for businesses to adjust.

This move will reshape the vaping market, pushing for sustainability and longevity in product design. Businesses that have relied on disposables will need to innovate and pivot their offerings to maintain market share post-ban.

For those new to the industry, avoiding investments in disposable products is a strategic move. For existing businesses, it's an opportunity to reassess and diversify their product lines. Alternatively, there are many markets overseas such as the UAE, where disposables are still highly in demand - perhaps consider tailoring your products to these other markets? Contact us for help in taking your products overseas.

Operation Joseph in Full Swing

Operation Joseph, a government-sponsored initiative, is at the forefront of the UK's drive to ensure vaping product compliance. This multi-agency operation brings together the MHRA, Trading Standards, The Chartered Trading Standards Institute, The National Trading Standards Strategic Intelligence Unit, and other regulatory partners to quash illicit sales to minors and combat counterfeit vaping products.

One of the operation's startling findings is that in quarter 1 of 2023-24, 25.3% of test purchases resulted in the sale of vaping products to minors. Similarly, in this same time frame, 749,806 illicit vapes were seized. These figures only highlight the growing need for action.

The implications for vape brand owners are clear—compliance checks are intensifying. It's now more critical than ever to have robust age verification systems and airtight regulatory adherence embedded into business practices.

Improper Submission Type

A concerning development from Operation Joseph is the detection of businesses misappropriating submission types, leveraging them to push through non-compliant products. This deceptive tactic of 'type-jumping' for product approvals not only circumvents regulations but also endangers public health by introducing untested or substandard goods into the market.

False or misleading information:

"49.  A producer or retailer is guilty of an offence if that producer or retailer provides information to a person pursuant to any obligation in these Regulations if—

(a)the information is false or misleading in a material particular; and

(b)the producer or retailer who provides the information either knows it to be false or misleading in a material particular,  or is reckless as to whether it is false or misleading in a material particular."

Those identified to be potentially false or misleading will be assessed and if determined to be misleading, false or notified using an incorrect submission type, will be deemed incomplete and removed from UK Publication until the required corrective action has been completed. The MHRA will inform you of the temporary decision and provide an opportunity to establish compliance of the Notification or take the appropriate corrective action. Once this has been completed the MHRA will review your response and publish the corrected notification or permanently withdraw the relevant Submission if compliance cannot be achieved.

For vape businesses, this signals the need for a transparent and honest approach to product submissions. Any shortcuts or attempts to skirt approval processes could spell legal and reputational disasters.

Misuse of the MHRA Logo

An unexpected discovery of Operation Joseph's investigations was the improper use of the MHRA logo by some vape businesses. This contravenes regulations that prohibit the use of the MHRA's insignia in marketing materials without express permission.

Misrepresentation through logo misuse is a deceptive practice that compromises consumer trust and portrays an unauthorized endorsement. Brand owners must take this revelation as a warning, ensuring their marketing is both legal and ethical, with close attention to logo usage guidelines.

In conclusion

The essence of these updates is clear: the vaping industry is under the microscope, and ignorance of the law is no excuse. Staying informed and proactively adjusting business operations to align with regulations is the safest course to sail in this new era of compliance vigilance.

While these updates might seem daunting, they also present opportunities for businesses to differentiate themselves through transparency, superior products, and strong corporate responsibility.

In conclusion, navigating the shifting vaping regulations with diligence and foresight will not only keep you on the right side of the law but will also earn you consumer respect and loyalty. As updates continue to roll out, we'll be here to keep you informed and your business ahead of the curve.

Incoming UK Disposables Ban: Getting Ahead of the Ban

The winds of change are upon the vaping industry once again, as the UK government’s plan to ban various disposable vape products comes into sharper focus. For brand owners and businesses entrenched in this dynamic market, the need to pivot and explore sustainable alternatives is not just a forward-thinking strategy — it’s a necessity in the face of impending legislation.

The Disposables Ban: A New Direction for Vaping

The proposed ban, a response to the rise in youth vaping, will prohibit the sale of certain flavoured E-Liquids and the often-criticized disposable E-Cigarettes. The ban aims to safeguard the younger generation against the potential harm and lifelong addiction risks associated with various nicotine products.

With the end of 2025 being the target date for the ban, businesses must quickly adapt to new regulatory measures and explore how to transition their offering to approved products. This shift is more than just a compliance task; it’s an opportunity for brands to align with consumer values and establish a long-term, responsible presence in the market.

Implications for Businesses

For enterprises still heavily reliant on disposable vape sales, the ban could signal significant operational and financial implications. Ranging from inventory management to supply chain restructuring, the effects will cascade down the business models, requiring comprehensive overhauls. Still, the ban presents a promising horizon, encouraging innovation and diversification across the industry.

The Alternatives: A Path to Sustainability

Staying ahead in the competitive market means offering something unique and in demand. As disposables phase out, there are several product lines that brand owners can consider maintaining their edge.

E-Liquids for Refillable Devices

One of the most popular alternatives is the thriving market for E-Liquids designed for use with refillable devices. This not only capitalizes on the sustained popularity of vape products but also promotes reusability and waste reduction. Manufacturers can capitalize on this by offering an array of E-Liquids in terms of flavours, nicotine strengths, and ratios.

Pod Devices: The Middle Ground

Pod devices serve as a comfortable bridge for consumers making the transition. Offering the convenience of disposables with the sustainability of a rechargeable model, these products are poised to captivate the market’s adaptable segments. Brands can develop their lines with sleek devices that boast long-lasting battery life, and versatile features, combined with their E-Liquid formulations to entice their customer base.

Other Nicotine Delivery Products

Beyond E-Cigarettes, there is a burgeoning demand for alternative nicotine delivery methods (ANDs), which include heated tobacco products and various non-combustible options such as nicotine pouches and sprays. This diversification allows businesses to pivot within the larger nicotine market and explore adjacent territories that align with their production capabilities and brand identities.

Case Study: Pioneering Paths

The transition from disposables to sustainable nicotine products is not new — it’s a trail already being blazed by industry leaders.

Innovating with Sustainable Kits

One such pioneer is Pod Salt, an award-winning British E-Liquid brand. Their latest innovation, Pod Salt Evolve, is a pod device kit that delivers both performance, satisfaction, and sustainability. By offering a product that addresses the legislative changes without compromising on user experience, Pod Salt exemplifies the success possible through strategic innovation.

Conclusion: Embracing Change with Xyfil

The disposables ban, although a significant shift, is a challenge that the robust vaping industry can navigate with innovation and adaptability. Xyfil, a leading vape manufacturer in the UK, has proven expertise in helping businesses successfully pivot to compliant and popular E-liquid lines.

For businesses looking to evolve their offering, Xyfil stands as a trusted industry partner, capable of swiftly manoeuvring through the complex regulatory landscape and emerging with products that win both consumer preference and regulatory approval.

As the market reshapes in the wake of the disposables ban, teaming up with Xyfil can be your strategic advantage — ensuring that your brand's future is as sustainable as it is successful. Contact us today to begin your journey towards transforming disposables into compliant, award-winning E-Liquids poised to lead the next wave of the vaping industry in the UK and beyond.

New Zealand’s Revamped Vaping Regulations: What to Know

The world of vaping is dynamic and ever-evolving. Over the past decade, it has grown from a niche habit into a global industry worth billions. As its popularity has surged, so too has the attention of regulators. Across the globe, countries are grappling with how best to regulate this new industry. The balance is a tricky one - ensuring the safety of users and those around them, while also recognizing the role vaping can play in helping people quit smoking.

In Aotearoa New Zealand, the government has recently unveiled a thorough update to its vaping regulations. These regulations, set to roll out by October 2023, reflect the country's commitment to reducing smoking rates and achieving a smokefree goal by 2025, all while navigating the challenges of a rapidly changing industry.

New Zealand's Newest Regulations for Vaping

Soon, the landscape of vaping in New Zealand will undergo significant changes. The recently announced updates to the vaping regulations indicate a balanced approach from the government. They are focused on making vaping safer and more controlled, particularly in relation to underage vaping while continuing to appreciate the potential benefits of vaping for those trying to quit traditional smoking.

These new regulations stipulate that future specialist vape retailers should be situated at least 300 meters away from schools, vaping products should be labelled with generic flavour descriptions, and there are now stricter limits on the allowed nicotine strength in disposable vaping products. Moreover, vaping devices will now be required to have removable batteries and child-safe mechanisms.

The Roadmap for Changes

As New Zealand embarks on an ambitious journey to reshape its vaping landscape, a detailed roadmap has been laid out to ensure a smooth transition. The first part of this transformative journey is the new ruling that all future specialist vape stores must be located at least 300 meters away from schools. This strategic move, set to commence in September, has been designed to protect the younger population from undue exposure to vaping, aligning with the overarching goal of mitigating underage vaping.

The implementation process is expected to be gradual, allowing businesses ample time to adjust to the new norms. For a full roadmap of the changes, you can find them on the government website. But by December 2023, retailers must only sell single-use vaping products that meet Product Safety Requirements (including nicotine limits, removable batteries, child safety mechanisms, and labelling requirements).

How Xyfil Can Help

At Xyfil, we're not just about producing vape products, we're an end-to-end vape manufacturer dedicated to helping our clients navigate the evolving landscape of vaping regulations. With the upcoming changes, it's essential for brands to adapt their product offerings, including labels and packaging, to ensure compliance with New Zealand's new rules.

Our in-house creative studio is equipped with the necessary tools and expertise to help brands make these adjustments smoothly. Through proactive collaboration, our team can work with you to redesign your product labels and packaging, adhering to the new generic flavour description requirement and other regulatory guidelines. With Xyfil by your side, navigating the future of vaping in New Zealand becomes a manageable task, allowing you to focus on delivering high-quality vaping products to your customers.

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.

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.

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.