Chapter 3 - Emissions guidance - Great Britain

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides essential guidance for manufacturers and importers regarding the mandatory notification of e-cigarette and vape products for the Great Britain market. Operating under the Tobacco and Related Products Regulations 2016 (TRPR), the MHRA requires that all entities submit a formal notification of intent at least six months before a product is placed on the market. The primary focus of this guidance is the rigorous reporting of emission data to ensure consumer safety. Main regulatory issues typically involve insufficient data regarding the chemical composition of the aerosol produced during use. Specifically, companies must provide precise measurements for nicotine delivery and consistency, along with levels of toxic substances such as aldehydes (including formaldehyde and acrolein) and heavy metals like lead and nickel. Required actions for compliance include conducting standardized laboratory testing that reflects normal usage conditions and ensuring all ingredients and their respective emissions are fully disclosed through the MHRA's submission portal. Failure to adhere to these reporting standards or omitting required toxicological data constitutes a violation of the TRPR, leading to the prohibition of product sales. This framework ensures that only products with verified safety profiles reach the public, placing the burden of proof for safety and quality directly on the commercial notifier.