Emissions testing
with regulatory registration

Emissions and regulatory registration service: e-liquids, pods and devices

In May 2016, the UK government introduced the Tobacco & Related Products Regulations (TRPR) to establish minimum safety and quality standards in vaping products (e-cigarettes and refill containers).

Manufacturers must notify each product to the MHRA (Medicines and Healthcare products Regulatory Agency) on their portal before sale, and include data on:

  • ingredients

  • emissions testing

  • toxicology reports

  • packaging information.

Countries within the European Union (EU) are governed by the Tobacco Product Directive 2014/40/EU (TPD). Products are notified to the EU-Common Entry Gateway (EU-CEG).

At ADACT Medical, we have over 20 years experience of regulatory compliance and analytical testing. We are the longest serving and one of the largest compliance agencies in Europe, having helped over 350+ businesses. Our in-house laboratory is accredited by UKAS for CBD testing and a range of analytical vape tests.

As an independent compliance company, we are trusted by flavour houses, having strict confidentiality agreements in place. That means we have full access to formulation data allowing a thorough, in-depth toxicological review of product formulations.­­

We have developed our own bespoke software system with over 750 toxicological reports and safety assessments, which helps compile and upload specific formulation and market data to the required regulatory authority.

The MHRA reviews products submitted to them, and if successful, they are published on EICG Dynamic Search.

  • In May 2016, the UK government introduced the Tobacco & Related Products Regulations (TRPR) to:

    • protect public health, especially young people

    • ensure products such as e‑cigarettes meet safety and quality standards

    • improve transparency through strict labelling and notification requirements.

    The requirements are:

    • e-cigarette tanks maximum capacity 2ml

    • maximum volume of nicotine-containing e-liquid in a refill container 10ml

    • e-liquids nicotine strength of no more than 20mg/ml

    • nicotine containing products or their packaging to be child-resistant and tamper evident

    • ban certain ingredients including colourings, caffeine and taurine

    • labelling & packaging requirements and warnings

    • all e-cigarettes and e-liquids be notified and published by the MHRA before they can be sold.

  • In 2014, Member States of the European Union adopted the Tobacco Products Directive 2014/40/EU (aka TPD2) and fully implemented it in May 2016 to:

    • reduce smoking rates, especially amongst young people

    • ensure vape products meet safety and quality standards

    • harmonise rules across the EU.

    TPD2 introduced:

    • packaging & labelling requirements eg health warnings

    • ban on characterising flavours

    • ingredient and toxicology data

    • maximum 20 mg/ml nicotine concentration in e-liquids

    • maximum 10 ml refill bottle size

    • maximum 2 ml tank size for devices

    • child-resistant packaging.

  • Our service includes:

    • full toxicological formulations review

    • emissions testing and certification (either 0mg and/or highest nicotine strength)

    • generation of safety data sheets for all SKU’s in up to four languages

    • labelling review and support

    • addition of branding

    • completion of documentation

    • building and compiling the submission with full formulation review and toxicology assessment, supported by our toxicology data and market reports

    • submission and filing of the complete technical dossier to the relevant competent regulatory authorities. 

    Note: A country of registration may charge a listing fee that is invoiced directly to you.

Short-fill, long-fills and aromas compliance

Zero nicotine short-fills, long-fills and aromas must meet General Product Safety Regulations (GPSR) 2005 - they must be safe for consumers. Although, they are currently not covered by TRPR in the UK, in certain parts of Europe, such as Germany, they are covered by TPD.

Our other compliance services include:

ISO/IEC 17025:2017
accredited testing:

  • analytical testing using best-in-class GC-MS

  • expert knowledge in regulatory compliance

  • step-by-step support through the regulatory process

  • in-house developed submissions generator.

Phone our friendly team or email hello@adactmedical.com.

We look forward to speaking with you soon.

CALL 01302 986088