Chapter 6 - Ingredient guidance - Great Britain

AI Summary

This guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory requirements for manufacturers and importers intending to market e-cigarettes and refill containers in Great Britain. Governed by the Tobacco and Related Products Regulations 2016 (TRPR), the regulatory framework demands a notification of intent to market products at least six months prior to sale. The primary regulatory focus is on chemical safety and transparency. Key violations often involve the use of prohibited additives or insufficient toxicological data. Products must not contain vitamins, caffeine, taurine, or any substances with carcinogenic, mutagenic, or reprotoxic properties. Furthermore, colorants intended to tint emissions are strictly banned. Required actions for companies include submitting comprehensive ingredient lists—specifying CAS numbers, functions, and quantities—alongside detailed emission studies and safety assessments via the MHRA submission portal. A notification fee is mandatory for each product. Compliance is verified when the MHRA adds the product to its published list of notified e-cigarettes. Failure to meet these documentation standards prevents legal marketing and may result in the removal of products from the British market.