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E-Liquid Regulations
Author Huw Leave a comment Categories Compliance, E-liquid, Regulations Posted on

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!

Author Huw Leave a comment Categories Manufacturing, Regulations, White Label, Xyfil Updates Posted on

How To Launch Your E-Liquid Brand in 2021.

Getting To Grips With The Market

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

Gaining Legal Recognition

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

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

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

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

The Perfect Marketing Window

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

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

Time To Get Started!

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

Create your own brand
Author Huw Leave a comment Categories CBD, White Label Posted on

5 Things You Need To Know About CBD

What is CBD?

CBD’s efficacy and versatility has earned it a prime spot in countless products across various industries, from cosmetics to the vape industry, food and drink, and health supplements. You’ll find it in almost everything from body butters to beers, but in spite of this much deserved hype, a lot of people are still in the dark about CBD’s origins and uses. Let’s run through some CBD essentials, and some of our favourite CBD facts.

CBD Is The Main Component of Cannabis

First things first, what is CBD, and where does it come from? Cannabidiol, or CBD, is one of 120 cannabinoids that makes up the cannabis plant. CBD is a non-intoxicating and non-euphoric psychoactive cannabinoid – meaning it can be great natural supplement to help you relax without getting you “high”.

Differences Between CBD Oils

Not all CBD oils are the same. Typically, they fall into three categories:

Full Spectrum – containing the full spectrum of CBD, including minor cannabinoids, cannabis-derived terpenes, and trace amounts of THC.

Broad Spectrum – containing a full spectrum of cannabinoids and terpenes, but without trace THC.

Isolate – a pure form of CBD with all other compounds removed. While some branding can be unclear about which category is contained in some products, it’s important to be sure which type you are buying. THC is a euphoric psychoactive cannabinoid, and as such does produce highs. THC is broadly illegal, and can increase depression and psychosis.

The Human Body Produces Cannabinoids

We know, sounds like science fiction, doesn’t it? But it’s true

Our bodies contain endocannabinoid systems, or ECS, complex cell-signaling systems with receptors in your central nervous system and peripheral nervous systems, particularly our immune cells. Research into ECS is still in its infancy – having first been identified in the 1990s – but scientists have so far uncovered that the ECS plays a role in regulating various body functions including sleep, mood, memory, and reproduction.

Our biological cannabinoids can help relieve pain, reduce inflammation, support the immune systems and ease symptoms of autoimmune disorders. It’s also been found that using CBD products as an additional supplement can help maintain our endocannabinoid systems, alongside the relaxation support offered by CBD supplements. A win win!

CBD Can Help Cancer Patients Manage Symptoms

Cancer is one of our most prolific diseases and innovative research is consistently increasing life expectancy and quality of life for sufferers year on year. Amongst this research, CBD has been touted to be a worthwhile aide to help cancer patients manage their symptoms.  

Cancer Research UK reports laboratory research so far as shown that CBD can cause cancer cell death or block cancer cell growth, stop the development of blood vessels which are needed for tumors to grow, and reduce inflammation. Although studies have had mixed results and more research is needed before anything conclusive can be decided, early discoveries are promising for the capabilities of CBD in cancer management.

CBD May Be a Helpful Supplement for Children

As CBD is non-intoxicating and non-euphoric, it is safe to give to most children in certain formats. In this article from Daily CBD, reviewed by Dr Abraham Benevides, M.D., gummies and low percentage oils are cited as the most appropriate means for CBD intake for children.

CBD supplements have been cited to help alleviate symptoms of anxiety, insomnia, asthma and nausea, as well as some skin conditions. It is, of course, essential to monitor CBD dosage when supplementing for children, and certain products – such as vapes – are not appropriate.

Doozy Vape Co
Author Huw Leave a comment Categories Case Studies, White Label Posted on

E-liquid Brand Case Study: Doozy

Who are Doozy?

Doozy Vape Co is proud to be recognised as a multi-award-winning premium E-liquid brand. Established in 2015 and defined by a genuine passion for vaping, Doozy has grown to become one of the world’s most distinctive vape brands, specialising in high quality E-liquid in a unique variety of flavours.

Our Business Partnership

Doozy and Xyfil have a long shared history in the vaping industry. Both E-liquid manufacturers were established at a similar time and are based in the North of England. We work closely on packaging, labelling, design and our co-packing manufacturing arrangements. We understand the true value of working together in this market for our mutual benefit; a business partnership we look to extend to other start-ups and established companies alike. Xyfil is experienced in providing flexible co-packing arrangements whereby a company can supply us with their e-juice flavour concentrates and we then complete the process by adding PG, VG and our award-winning Nicotine salt formula.

What are Nicotine Salts?

Nicotine salts are found naturally in tobacco leaves and consist of nicotine and salicylate, which we then extract to produce our E-liquids. Nic salt represent an evolutionary step in quality from standard freebase nicotine, offering vapers enhanced nicotine delivery, greater satisfaction and a far smoother experience.

Xyfil’s advanced Nicotine Salt formula is designed to provide an exceptionally smooth vaping experience at high nicotine strengths. Naturally found in tobacco leaves, salicylate lowers the pH of nicotine, reducing irritation on the throat and providing enhanced nicotine delivery. Our formula is engineered for low vapour production, bringing an element of stealth and discretion to your vaping.

What can Xyfil do for you?

We are one of the leading UK E-liquid, personal care products and CBD manufacturers supporting brands worldwide as their businesses develop. We provide end-to-end white label manufacturing services, helping you develop your brand at every stage from flavour development to the design and production of your liquids. We offer TPD E-liquid compliance, regulatory compliance and E-liquid analysis so that you can have confidence in the quality and safety of your products.

TPD - Regulations
Author Huw Leave a comment Categories Compliance, Regulations Posted on

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.

Author Huw Leave a comment Categories Compliance, Regulations Posted on

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

Author Huw Leave a comment Categories Community, Xyfil Updates Posted on

Xyfil arrange an awesome staff BBQ.

As a big thank you to the Xyfil family for all their hard work and dedication, we arranged an awesome staff BBQ, supplied and beautifully presented by A2Z BBQ catering. Everyone was invited from across the business … production, operations, marketing, sales, accounts and HR.

Xyfil Family

Sometimes you just have to take five and remember we’re all part of something huge, it’s important we acknowledge everyone by saying thank you and letting you all know, it’s much appreciated, you’re really valued and if it’s right on the inside, it’s great on the outside!

Thanks to the amazing guys at A2Z for a delicious feast, you can find A2Z and their service by following the link: https://www.instagram.com/a2zbbqcatering/

2019/20 - BBQ
Author Huw Leave a comment Categories Case Studies Posted on

CBD Brand Case Study: Cali Greens

Who are Cali Greens?

Cali Greens is Xyfil’s primary in-house CBD brand. We specialise in premium-quality CBD products that are sustainably sourced and are based around your everyday needs. You can purchase on caligreens.co.uk.

Our unique range of skincare products, drops and vapes give you flexibility and peace of mind. In a world full of stress and anxiety, we pride ourselves on helping you live life to the fullest by supporting a healthy and balanced lifestyle.

What is CBD?

CBD stands for Cannabidiol, a natural extract of the Hemp plant that is perfectly legal and non-psychoactive. CBD won’t get you high in the psychoactive sense, but it can provide many other benefits including pain relief, anti-inflammation and CBD oil has been used as to reduce anxiety and depression in patients (Healthline, 2021).

CBD is different from THC, which is the psychoactive component found in marijuana. People often assume that Cannabis is the same as marijuana, but in reality, only a few plants in the Cannabis family contain THC. At Cali Greens, we extract our CBD from sustainable and legally grown hemp farms in Colorado, USA with no trace of THC.

Cali Greens Products

CBD E-liquids

E-liquids are designed to be vaporised by an e-cigarette device, allowing CBD to be absorbed into your lungs.

CBD Oil Drops

Liquid drops are designed to be taken orally, or for best results, placed under your tongue for 2 minutes to increase the absorption rate.

CBD Creams & Lotions

Topical creams are designed for your skin and allow you to target a specific area of your body.

Caligreens range

CBD Manufacturing at Xyfil

E-liquids

As a leading CBD manufacturer, our CBD E-liquid products are among the very best you will find on the market. Our products continue to surprise end users with their effectiveness and their superior taste. Generally, TPD E-liquids tend to use standard isolate but we can also offer full-spectrum CBD oil. Our production method allows us to make products at up to 2000mg strength without the need for any additional solvents. We also offer E-liquids with the added benefit of terpenes which helps modulate the impact of CBD as well as the taste profile.

Sub-lingual Drops

Sub-lingual drops are essential in any CBD range. Their main benefits include high bioavailability and universal accessibility – unlike vaping, everyone will feel comfortable and confident in using them. Holding a tincture under the tongue for 2 minutes increases bioavailability to 45%, making drops a useful product in your range.

Creams

Xyfil have developed a range of award-winning topical cream formulations in-house. The highlight is our micellar formula which is non-greasy and is rapidly absorbed into the skin. We offer white-label manufacturing services for body butters, creams, gels and balms similar to the Cali Greens range. Here, you can specify the active ingredients including CBD type and strength, essential oils, vitamins and terpenes.

Author Huw Leave a comment Categories Hand Sanitiser, Xyfil Updates Posted on

Xyfil on the front line of hand sanitiser production in the UK.

Xyfil – Press Release

In 2020, Xyfil diverted 80% of its operations to the production of hand sanitisers and PPE. With over 50,000 bottles of alcohol-based sanitiser every day, our production facility is at the frontline of hand sanitiser manufacturing in the UK.

Our team from compliance, R&D, production, design and engineering have joined forces to support the project and get it off the ground in record-breaking time. Xyfil CEO Mr Hansrod stated:

“Our clean rooms and physical bottle supplies on the ground make us ideally placed to help serve this emergency, but it is the desire of our teams and suppliers to help and feel useful at this time of need that has got this project realised. We are incredibly proud of the work everyone has done.”

At over 50,000 bottles of alcohol-based hand sanitiser produced per day, Xyfil’s production facility is at the frontline of this national crisis, supporting NHS Trusts, local care homes and pharmacies that are currently struggling to provide enough hand sanitiser for everyone. Xyfil’s hand sanitiser formulation, which is as per WHO (World Health Organisation) guidelines, kills 99.9% of all bacteria - with a little something added to be kind to your hands.

The Preston manufacturer is well-equipped for large-scale bottling and labelling, with ISO 7 laboratory facilities and a fast-paced production line. As manufacturing operations diversify, Xyfil is recruiting extra staff during this time and retaining key employees on site to keep up with the high demand. E-liquid manufacturing remains active within the business and suppliers are still encouraged to make enquires and orders.

Supporting the local community is an important factor for the company directors. Hand sanitiser will be provided to local NHS Trusts, pharmacies and care home providers as a priority. The general public will also be able to purchase hand sanitiser products from Xyfil’s retail and distribution partner, My Vapery at www.myvapery.com.

Xyfil is calling all care home providers, pharmacies, NHS Trusts and other frontline institutions that require hand sanitiser to get in touch on 01772 888 778 or to visit www.xyfil.com for more information.

If you would like more information on this release, please direct all press enquires to info@xyfil.com, or call +44(0)1772 888 778. www.xyfil.com
Xyfil Ltd T/A My Vapery 15-19 Sedgwick Street, Preston, PR1 1TP, United Kingdom.
Author Huw Leave a comment Categories Case Studies, E-liquid Posted on

E-liquid Brand Case Study: Pod Salt

What is Pod Salt?

Pod Salt is a dedicated nicotine salt E-liquid brand produced exclusively by Xyfil. The award-winning, British-made E-liquid collection provides the smoothest and most refreshing vaping experience that is designed to hit the spot. You can purchase at podsalt.com.

Pod Salt’s premium nicotine salt formula is absorbed faster, lasts longer and produces a greater level of satisfaction than traditional E-liquids. The Pod Salt Core range offers a premium selection of classic and refreshing flavours. Our Fusion range brings you the world’s biggest brands, blending their signature flavours with our award-winning Nicotine Salt.

Pod Salt is committed to helping smokers make the switch from tobacco to vaping by providing the best possible alternatives. We offer support and guidance to help you your journey. Millions of people have already made the switch, start today and transform your life with Pod Salt.

What are Nicotine Salts?

Nicotine salts are found naturally in tobacco leaves and consist of nicotine and salicylate, which we then extract to produce our E-liquids. Nicotine salts represent an evolutionary step in quality from standard freebase nicotine, offering vapers enhanced nicotine delivery, greater satisfaction and a far smoother experience.

Xyfil’s advanced Nicotine Salt formula is designed to provide an exceptionally smooth vaping experience at high nicotine strengths. Naturally found in tobacco leaves, salicylate lowers the pH of nicotine, reducing irritation on the throat and providing enhanced nicotine delivery. Our formula is engineered for low vapour production, bringing an element of stealth and discretion to your vaping.

Who manufactures Pod Salt?

Xyfil is primarily an E-liquid manufacturer dedicated to producing premium e-juice flavour concentrates for our external and in-house brands. As one of the leading vape E-liquid manufacturers in Europe, we manufacture for hundreds of global brands with Pod Salt being at the forefront of our E-liquid operations, now sold in over 20 countries.

Expanding operations to the Middle East.

Pod Salt is one of the best and most widely recognised nicotine salt brands in the UK, Europe and Dubai. When restrictions were eased in 2019, the UAE market allowed a gateway into the Middle East for premium E-liquid brands. This presented an opportunity for Xyfil. We quickly set up manufacturing operations in the UAE and opened dozens of My Vapery Stores in Dubai and Abu Dhabi.

What can we do for you?

We are one of the leading UK E-liquid, personal care products and CBD manufacturers supporting brands worldwide as their businesses develop. We provide end-to-end white label manufacturing services, helping you develop your brand at every stage from flavour development to the design and production of your liquids. We offer TPD E-liquid compliance, regulatory compliance and E-liquid analysis so that you can have confidence in the quality and safety of your products. Why not drop us a line or get in touch at info@xyfil.com.

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