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

Category Archives: Regulations

TPD - Regulations

What is TPD ?

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

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

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

The TPD introduced rules which require:

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

Their specific requirements mean producers must:

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

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

What Does TPD Mean for My CBD Brand?

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

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

How Does Xyfil Approach TPD Certification?

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

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

Work with Xyfil for TPD Accredited CBD Products

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

E-cigarettes: regulations for consumer products by UK GOV

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

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

The TRPR introduced rules which ensure:

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

The requirements:

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

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

An Explanatory Memorandum explains the changes from a policy perspective:

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

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

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

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