Chapter 6 - Ingredient guidance - Northern Ireland

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides specific guidance for companies notifying e-cigarette and refill products for the Northern Ireland market. Operating under the Tobacco and Related Products Regulations 2016 and the Windsor Framework, manufacturers must submit detailed ingredient information via the European Common Entry Gate (EU-CEG) portal at least six months before intended marketing. The main requirements involve disclosing a full list of ingredients, including Chemical Abstracts Service (CAS) numbers, specific functions, and exact quantities. Companies must also provide comprehensive toxicological data regarding the ingredients effects on human health when inhaled or heated. Potential violations of these standards include the use of prohibited additives such as vitamins, caffeine, or stimulants that suggest health benefits, as well as substances that color emissions or possess carcinogenic properties. To remain compliant, businesses are required to ensure all submissions are complete, accurate, and updated whenever product formulations change. Failure to provide sufficient data on emissions and ingredient safety will result in the product being ineligible for legal sale within Northern Ireland. The MHRA maintains oversight to ensure that only products meeting these rigorous safety and transparency standards reach consumers.