By Dr Pete Gibbons, Head of Reduced-Risk Product Analysis at Hall Analytical
The Reduced-Risk Product (RRP) sector is predicted to grow significantly in worldwide marketplaces over the next decade. Global nicotine consumers are switching in great numbers to reduced harm alternatives from traditional combustible tobacco.
Product innovation continues to move at an accelerated pace in the RRP industry, with improved and safer nicotine-delivery products being developed for consumers in highly regulated markets. The rapid growth of the ENDS market in the UK and EU over the last 10 years has also resulted in the implementation of regulatory frameworks (TPD 2 & national transpositions into domestic law) and early attempts at standardisation of ENDS manufacture and testing requirements. ENDS industry stakeholders sponsored and produced a Publicly Available Specification (PAS) through the British Standards Institute (BSI) in 2015 and AFNOR (standards organisation of France) published requirements and test methods for ENDS in the same year.
European (CEN) standards
The BSI and AFNOR documents provided guidance to a rapidly expanding ENDS industry, and it was recognised that European (CEN) and international standards (ISO) would be required to ensure RRPs were manufactured to a high standard, with regulators also having access to high-quality product data from standardised methodology. Technical experts, many working directly or in support of the nicotine industry, were tasked with forming working groups to discuss technical issues and provide solutions. Senior scientists at Hall Analytical were proposed to serve on the various working groups as technical experts. CEN / TC437 (standardisation in the field of e-cigarettes and e-liquids) has six sub-committees working on a range of standards, from requirements and test methods for ENDS/e-liquids to ENDS emission test methods. Hall Analytical has been especially busy on working groups 3 and 5, namely requirements and test methods for e-liquids, and extractables and leachables (E&L). With our extensive experience of e-liquid analysis and working knowledge of e-liquid manufacture and ingredient toxicology, our subject matter experts have made significant contributions to forthcoming standards for quality testing, manufacturing requirements, and e-liquid ingredients. We expect the final versions of the documents to be published in the new year.
Recognised thought-leaders for E&L study design to support the ENDS industry
In the specialist area of extractables and leachables studies, Hall Analytical is recognised as one of the UK’s leading laboratories. When assessing ENDS/e-liquid product safety, robust E&L studies are required to demonstrate any potential chemical substances which leach into the e-liquid from product components (and subsequently transfer to users via aerosol) are within acceptable toxicologically evaluated thresholds. We’ve used our expertise in E&L studies for ENDS clients to lead the drafting of the European standard. Dependent on the outcome of the CEN enquiry process, we’d expect publication of this standard to follow in late 2022.
International (ISO) standards for vaping products
ISO TC 126 SG 3 committee works on terminology, testing methods, and product information for vape and vapour products. Two ISO standards have been published to date, one describing routine analytical vaping machine conditions, and the other the determination of nicotine, propylene glycol, and glycerine in e-liquid. Experts from around the world are currently working on several projects to standardise the procedures for the collection and analysis of emissions from vaping products. Projects include the determination of e-liquid vaporised mass and aerosol collected matter, emissions of carbonyls/metals, and determination of nicotine in vape product emissions. Hall Analytical serve on the TC 126 SG 3 committee following nomination by BSI.
Modern Oral Nicotine (MON) pouches and CBD vaping products
The contribution to the development of standards from Hall Analytical has not only been limited to ENDS. We’re actively participating in current and forthcoming Publicly Available Specifications (PAS) for tobacco-free modern oral nicotine pouches and CBD vaping products. PAS 8877 will provide guidance for the manufacture and testing of modern oral nicotine pouches, with publication due in the Spring of 2022. The technical steering group for the PAS on CBD vaping products will meet for the first time early in the new year.
So, we hope you’ve found this brief look at standards for the RRP sector to be informative. Hall Analytical can help your business comply with regulatory and/or product testing standards. With over 10 years’ experience in Reduced-Risk Product testing, we’re recognised as the laboratory partner of choice for the nicotine product sector. Please get in contact today for a free consultation.