Electronic Nicotine Delivery Systems (ENDS), also called electronic cigarettes, e-cigarettes, vaping devices, or vape pens, are battery-powered devices used to smoke or “vape” a flavored solution which usually contains nicotine.

Across the EU, the Tobacco Products Directive (TPD) is the applicable overarching directive for these products. This directive lays down the minimum requirements necessary for regulating tobacco and tobacco related products. From this directive, member states create national legislation. When creating national legislation, the TPD provides guidelines but does not have to be adhered to word for word, so between member states there is some variation. 

In GB, the national legislation in place is the Tobacco and Related Products Regulation (TRPR, 2016).

Tobacco product directives and regulations were proposed as a measure to ensure a minimum level of safety and quality for tobacco products placed on the market. Prior to these being implemented, numerous formats were used for notifying products to regulatory authorities, causing manufacturers and importers to be met with difficulty when trying to correctly report the relevant information. This resulted in Member States also having trouble keeping track, analysing and making decisions based on this information. 

The overarching aim of TPD and TRPR is to maintain consumer safety and awareness of the inherent risks associated with the use of tobacco products, based on protection of human health, especially concerning young people, and to meet the obligations of the Union under the WHO Framework Convention for Tobacco Control (‘FCTC’). It also contributes to the facilitation of the smooth functioning of the internal market for tobacco products.

Both are in place to regulate:

From January 2021, due to the UK exiting the EU, two different portals are used for e-cigarette notifications. The EU will continue to use the EU Common Entry Gate (EUCEG). Whereas, GB will begin to use the Medicines and Healthcare products Regulatory Agency (MHRA) portal. To notify products in Ireland, EUCEG will continue to be used.

For notifications in EU countries you have to wait 6 months from submission before products can be placed on the market. 

However in GB, a list of declared products is available and if your product is listed before the six months timeline, you do not need to wait for the remainder of the time before placing products on the market.

Countries throughout the EU may have different requirements for packaging in terms of language. Some countries do require packaging to be in English and/or the national language of the country.

Fees for notifications can vary from country to country, with some countries allowing notifications for free whereas others can charge up to 1000 euros per product. 

For products to be placed on the EU market, an authorised representative is needed and is required to be based in the EU.

Similarly, products placed on the GB market require an authorised representative to be based in GB. 

Our experts can assist you in every stage of the product life-cycle from product development, to through to post launch activities, including:-

We continuously contribute to expert working groups to set product standards and influence policy with governments in the areas of vaping devices (these include the TPD requirements). For example, our team is involved in the CEN TC 437 WG 2, 3 and 4 for the generation of standards for ENDS in Europe, and the BSI:PAS 8850:2020 for Heated tobacco products  

Within these working groups, we use our knowledge gained from 12 years experience in regulatory affairs and analytical testing for nicotine e-liquids and e-cigarettes, medical devices, novel devices and pharmaceutical products.

Whether you’re a one-person start-up or a multinational organization, we can create a TPD / TPRP bespoke service to your needs, saving you time and cost and ensuring your ENDS products are safe and legal. Contact info@inter-scientific.com to get a tailored quote. For regular updates, follow us on LinkedIn.

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