Report

February 19

CJEU Advocate General Opinion, EU Tobacco Regulations Valid

Since the issue of the EU Tobacco Products Directive of 2014, many counter arguments have been put forward against certain aspects of the new ruling relating to e-cigarettes, such as the banning of advertising and certain restrictions of product design characteristics. Since the challenges have been submitted, Electronic cigarette manufacturers and their supporting partners such as emission testing laboratories have been awaiting judgement on the validity of the rules, to be decided by the Court of Justice of the European Union (CJEU). On the 23rd of December 2015, the Court of Justice of the European Union issued a press release outlining the Advocate General’s Opinions in Cases C-358/14, C-477/14 and C-547/14.

TPD Rules are Valid

In the release, Advocate General, Juliane Kokott, has upheld the validity of the TPD. The Advocate General finds that the rules for e-cigarettes differ appreciably from the rules for conventional tobacco products. However, she finds that differences are moderate and not disproportionate to the rules for conventional tobacco products in the EU and in comparison to international standards.

The Advocate General’s opinion is not binding on the Court. The Judges consider opinions in their deliberations, which they are beginning now and are expected to deliver later in 2016. In an article by Cancer Research UK, Deborah Arnott, chief executive of health charity ASH, says that the Court’s decision is likely to be in line with the Advocate General’s opinion.

Rapidly Developing Market

Advocate General Kokott states that the market for e-cigarettes is developing rapidly as the product is novel and little known to large parts of the population. She states that rules are required to elevate the significance of electronic cigarette’s nicotine content and to harmonise rules among the Member States.

Alison Cox, Cancer Research UK’s director of prevention, states that the Advocate General’s opinion is appropriate and is a “light touch” that respects the balance necessary to protect non-smokers and children while making products available to help people stop smoking conventional cigarettes.

E-Cigarette Manufacturing

Assuming that the final opinion of the Court is in line with the Advocate General’s review, all manufacturers and distributors of e-cigarettes will be required to test their products to comply with the new legislation by May 20th 2016. Analysis of e-liquids, vaping devices and emission testing of vaping products is a highly specialised undertaking, requiring experts in the analysis of electronic cigarettes. Such product testing packages may comprise the determination of nicotine, carbonyls, metals, impurities within the product emissions and evaluation of shelf life (stability testing).

Download Broughton Laboratories’ leaflet to learn more about the EU Tobacco Products Directive (TPD), content analysis, emission testing, and software packages. Utilise our complete solution to stay ahead of the curve as the rules evolve so you can compete successfully in the rapidly developing market of e-cigarettes and other ‘vaping’ products.

About the Author

Chris Allen is the Chief Scientific Officer at Broughton Nicotine Services. Since obtaining a Bachelor of Science degree in chemistry, Chris has gained over 20 years of analytical and regulatory experience working in global Medical Device and Pharmaceutical companies and within leading Contract Research Organizations. Chris co-founded Broughton Nicotine Services sister company (Broughton Laboratories) in 2006 and played a pivotal role in obtaining the first UK Medicinal License for an Electronic Cigarette, a project starting in 2010. Now with over ten years of working with ENDS, Chris has become well established as a recognized SME in the regulations and chemistry of tobacco products. In the position of Chief Scientific Officer, Chris’ key objective is to support the acceleration of safer nicotine delivery products to market and to deliver value and unrivalled experiences to our customers.