May 20 is the Deadline to Comply with the European Tobacco Products Directive (EU TPD)
by: Maria Verven
Any e-liquid manufacturer selling in Europe must know what these initials mean, because it’ll be the law on May 20 this year. The European Tobacco Products Directive (EU TPD) has set reporting, guidance and restrictions on cigarettes since 2001 and in May, the TPD’s Article 20 will regulate e-cigarettes as well.
“The TPD will affect every e-liquid or e-cigarette manufacturer selling in any one of the EU’s 28 countries,” said Dennis Moore, founder and CEO of Chemular, a full-service regulatory consulting firm that boasts the largest team of compliance, manufacturing software and engineering experts specializing in the U.S. vaping industry.
Moore and the Chemular team are currently helping e-liquid companies gain compliance with the TPD while lowering their liability risk by following best of-class quality practices. A former FDA investigator and regulatory expert, Moore is highly qualified to help companies negotiate the TPD’s quality standards as well as the labyrinth inside the FDA.
What does complying with the TPD mean, exactly? The TPD requires companies to submit a dossier including detailed toxicology and emissions data on every flavor I every nicotine level that flavor comes in. A technical file must also be submitted on any new product at least six months prior to launch.
While hiring an attorney isn’t necessary, most companies need the guidance of regulatory and quality professionals to help them prepare the technical file and registration dossier. The process can take several weeks, and if the deadline isn’t met, sales are banned for six months.
What’s Wrong with the TPD
The main issue with Article 20 of the TPD – like the FDA’s deeming regulations – is it fails to recognize where vaping products fall in the risk continuum, according to Robert Burton, Chemular’s chief scientific officer and former head of regulatory affairs for White Cloud. “Cigarettes are the most harmful things on the tobacco harm reduction risk continuum,” said Burton. “But the way the TPD is written, it doesn’t support that.” Burton first started working with the TPD on the tobacco side over nine years ago. “Like many of these regulations, they’re not appropriate for vaping products,” he said.
“E-cigarettes and vaping products have been inappropriately squeezed into these regulations.” Regardless, the TPD is a fact of life that e-liquid companies will have to live with. The only exception is zero nicotine e-liquids or e-cigarettes; if they don’t contain nicotine, they don’t fall under the TPD.
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A simple way to remember three key hallmarks of the TPD is 20-20-10. May 20 is the deadline. 20 mg is the maximum nicotine concentration. And 10 ml is the maximum bottle size.
With May 20, 2016, as the final compliance deadline, each of the 28 European member states may adopt some or all of the TPD guidelines – or come up with its own. So far, Denmark, Finland, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain and the U.K. have fully adopted the TPD’s guidelines, while the Czech Republic, Germany, Ireland have partially adopted them.
Austria, Belgium, Bulgaria, Croatia, Cyprus, Estonia, France, Greece, Luxembourg, Malta, Romania, Slovenia and Sweden have yet to adopt any guidelines, although Moore expects these countries to simply adopt the TPD rulebook, as it stands.
“When you’re dealing with 28 member states, it’s quite a complicated matrix,” Moore said. He explained that the format of the dossier varies from member state to member state, depending on their sophistication and ability to deal with proprietary information. For example, some countries require an electronic ingredient disclosure while others ask for password-protected CD-ROMs, he said.
In another example, member states can demand the full health warning on e-liquid and e-cigarette packaging: “This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers.” A simpler version is also allowed: “This product contains nicotine which is a highly addictive substance.”
The TPD also demands that companies include a leaflet with instructions for use and storage of the product, warnings against use by young people and non-smokers, and contra-indications for specif ic risk groups such as pregnant women. Information on the product’s addictiveness, toxicity, potential adverse effects as well as contact details for the manufacturer or importer is also necessary.
E-liquid bottles must list all ingredients in descending order as well as indicate the exact nicotine concentration. Nicotine levels are restricted to 2 percent or 20 milligrams per milliliter.
Bottles and containers containing nicotine e-liquids must be child- and tamper-proof.
Plus, the TPD restricts the size of e-liquid bottles and tanks; bottles may not be larger than 10 ml and the device chamber size, including coils, may not exceed 2 ml.
“This, again, is counterintuitive,” Burton said. “Vapers, and especially those who desire higher nicotine concentrations, will have to carry around more liquid with them.”
Gaining Favor with Flavor Companies
Perhaps the greatest burden on e-liquid manufacturers is that the TPD demands they provide detailed specifications on each flavor and flavor ingredient.
A technical file, which includes a list of all ingredients, is much like a medical device file, Moore explained. The final dossier would include a toxicology assessment and emissions test on each SKU and ingredient along with the artwork, instructions for use and disclosure requirements for each member state.
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Moore said they’re doing preliminary emissions testing to see which flavors may be of most interest to regulators. “Some flavors such as cinnamon and licorice contain aldehyde molecules have raised some concerns,” he said.
The biggest hurdle may not be the time or money to complete this dossier, Moore said. The main sticking point could be with flavor companies that may be reluctant to divulge their flavor ingredients because they’re literally their secret sauce.
Moore said Chemular is working with flavor shops to create a third-party repository process where flavor shops submit detailed flavor compounds under a very strict non-disclosure.
Since it’s likely that the FDA will be on the same regulatory trail, Chemular is working to gain the confidence of flavor manufacturers to give up this proprietary information. “If the flavor facilities won’t divulge molecular information on their flavor compounds, they’re simply not going to survive in the newly regulated environment,” Moore said.
Getting Ready for REACH
Finally, the TPD will also require e-liquid companies to use REACH-registered chemicals. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a program initiated by the European Chemicals Agency to ensure the safety of major ingredients used in consumer products.
Going beyond U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP) standards, REACH will apply to nicotine, propylene glycol (PG), and vegetable glycerin (VG). As of this writing, only two nicotine manufacturers meet REACH standards – CNT and Nicobrand, Europe’s oldest producer of nicotine.
While not enforced until 2018, the TPD will require that these chemicals meet REACH standards. So every manufacturer not using REACH-approved nicotine, PG and VG will eventually have to reformulate their flavors and then resubmit files to the TPD.
The original “Vaping VampTM,” Maria Verven is a 35- year P.R. veteran and owner of Verve P.R, a marketing firm focused on the vape industry.