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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!

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