The TPD and Everything You Need to Know About Vaping in Europe
With the Federal Drug Administration cracking down on vaping throughout the U.S., Americans may think they can simply start ordering vaping liquid and supplies from other countries, like those in Europe (good luck with that).
Just as the U.S. is beset with the FDA’s deeming laws , the European Union has the Tobacco Products Directive (TPD). And regulations on both sides of the Atlantic are poised to pretty much snuff out the vaping industry as we know it.
The TPD sets forth new rules for nicotine-containing e-cigarettes and vaping liquids. Products covered under TPD include e-cigarettes and any components that contain or could contain nicotine in the form of vaping liquid. That means disposable e-cigarettes and components such as tanks are covered under TPD – but batteries, drip tips or other components that don’t hold vaping liquid are not.
You’ll find more in the fine print in TPD 2014/40/EU. And you’ll find the restrictions that apply to the 28 nations that are part of the EU depressingly similar to those being launched across the U.S.
The new rules introduced in the TPD set forth requirements in several areas:
- Safety and quality requirements
- Packaging and labeling requirements
- Monitoring and reporting requirements
- Notification requirements
Safety and Quality Requirements
The TPD dictates nicotine-containing e-cigarettes and vaping liquid containers must:
- Contain no more than a specified maximum nicotine concentration and maximum volume allowed for cartridges, tanks and vaping liquid containers.
- Maximum concentration is 20mg/ml (Nicotine levels higher than 20mg/ml will be classified as a medicine and must conform to regulations for medications)
- Maximum volume is 10 ml for vaping liquid containers and 2 ml for e-cigarettes
- Contain ingredients of high purity that deliver consistent nicotine levels throughout usage
- Be child-resistant and tamper-proof
- Have a mechanism that ensures refilling without spillage
Packaging and Labeling Requirements
The packaging and labeling rules for e-cigarettes dictate they include:
- Mandatory health warnings that advise consumers the e-cigarettes contain nicotine and should not be used by non-smokers
- Warnings that cover at least 30 percent of the packaging
- A list of all product ingredients and information on nicotine content
- A leaflet containing instructions for use along with information on detrimental health effects, risk groups, addictiveness and toxicity
- Absolutely no promotional elements
Cross-border advertising and promotion of e-cigarettes is also prohibited.
Monitoring and Reporting Requirements
The TPD additionally mandates monitoring and reporting requirements for industry manufacturers and importers, EU Member States, and the EU Commission:
- Manufacturers must inform Member States of all products they put on the market, issuing annual reports on sales volume, consumer preferences and trends.
- Member States must monitor the industry for evidence that vaping leads to tobacco consumption or nicotine addiction, particularly for non-smokers and youth
- The Commission must present an implementation report after five years, providing the European Parliament and Council with a rundown on the developments of e-cigarettes
Submitting a notification of products entering the market should be done at least six months before the product is intended to be sold. And based on the extensive information required in each notification, six months may be how long it takes for someone to actually read and review the notification.
Manufacturers and importers can submit notifications about their products to the MHRA (Medicines and Healthcare Products Regulatory Agency), which is like the British equivalent of the FDA. The submission process can be done online, with instructions from Gov.UK that walk you through the steps.
Each notification must include specific information:
- Type of product
- List of all ingredients in the product
- Emission testing results
- Toxicological data regarding all ingredients and emissions
- Level of nicotine uptake when product used under normal conditions
- Measurement methods used to gauge level of nicotine uptake
A number of fees come with submitting notifications of products. These fees include:
- £150: Notification fee for putting each new product on the market
- £60: Annual fee for keeping each product on the market
- £80: Substantial modification fee for any changes made to a product
The new rules set forth by the TPD will be rolled out of a period of time.
May 20, 2016
EU Directive transposed into national legislation by Member States of the EU.
Any in-stock merchandise related to e-cigarettes and vaping liquid can continue to be sold as it has been, although manufacturers and importers must now submit notifications.
Manufacturers and importers must submit a notification of all products already on the market as of May 20, 2016, or intended to be placed on the market thereafter. Notifications must be sent to the “competent authorities” of Member States, such as the MHRA.
November 20, 2016
Nov. 20 is the deadline for manufacturers to submit notifications for any products on the market before May 6, 2016. This also serves as the cut-off date for producing any new products that don’t comply with TPD regulations. All products introduced onto the market as of this date must comply with TPD requirements.
May 19, 2017
All merchandise that does not comply with the TPD must be removed from the market.
The only e-cigarette and vaping liquids on the market at this time must comply with the TPD and be backed up by a submitted notification.
Retailers can check to ensure notifications were submitted by checking with specific agencies in each Member State, such as the MHRA website in the U.K., which will have an available page when the time comes.
While the TPD does not outright ban e-cigarettes as some rumors have claimed, it does present a number of hoops, twists and turns manufacturers and importers must maneuver through to get new products on the market. Not to mention the steady slate of fees.
In addition to the initial and annual notification fees, manufacturers are also going to face increased costs for the revamped labeling, containers, testing and research that now must accompany each product that falls within the TPD purview. As with the FDA deeming regulations in the U.S., Europe’s TPD has the power to potentially decimate the vaping industry through extensive and expensive government controls.
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