The vape industry is subject to various legal e-liquid regulations. Complicated and irritating as the regulations may sometimes seem, they serve the safety of people who may get in contact with dangerous substances. Due to that, substances, like nicotine, have to be registered before being placed on the market. Check the key regulations in the vape industry.

NOTE: this article is part of our Beginner’s Guide to vaping, where – in one place – we have gathered for you all the relevant facts and background information you need to learn about the e-liquid industry and succeed in it as a manufacturer or brand owner.

Chapters:

1. Vaping: Basic Information
2. E-Liquids And Vaping Devices
3. Raw Materials In The E-Liquid Manufacturing
4. E-Liquid Regulations (You are here)
5. E-Liquid Market Trends

There are 3 main regulations regarding the European e-liquid market:

• TPD – Tobacco Products Directive
• CLP – Classification, Labeling and Packaging
• REACH – Registration, Evaluation, Authorization and Restriction of Chemicals

Keep in mind, that, aside from these 3 regulations, there are also laws regulated on a national level. Various countries introduce bans on flavored e-liquids or allow only a certain number of substances e liquids flavors can be made of.

Tobacco Products Directive is a regulation that has been influencing tobacco products for the past few years and applies to all the member states of the European Union. Tobacco Products Directive force on 20 May 2016. It limits the sales and merchandising of tobacco and tobacco-related products in the EU. By tobacco-related products, one means, among others, electronic cigarettes and refill containers.

TPD affects tobacco products in various fields. Not only, as mentioned, it limits the sales, but also e-cigarette advertising and promotion to minors, or the use of electronic cigarettes in public places. Additionally, the maximum nicotine concentration (nicotine strength) in nicotine vaping products is 20 mg/ml.

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TPD-notification

TPD also enforces importers and manufacturers to notify their e-liquids, vape products, and electronic cigarettes in terms of composition. One has to provide the full list of components to competent authorities of the Member States with detailed information, i. e., the list of substances released while using the product. It all serves to prevent the consumption of banned substances, i. e., CMR.

Additionally, notification allows gathering the data of products placed on the market to be stored in one place, in case of accidents and the need for identification.

Moreover, manufacturers have to conduct laboratory emission tests of e-liquids, to prevent the market from the inflow of harmful or contaminated products.

Such results are sent to the national authorities of the country where the product will be present, and they either agree or not, to register it. Keep in mind, that one product must be registered as many times, as there are countries for it to be sold.

TPD-packaging

TPD also imposes some guidelines on the packaging of tobacco and tobacco-related products. Manufacturers have to place appropriate health warnings on the unit and collective packaging. Furthermore, TPD sets the minimum size of warning signs and the appearance and content of the product’s packaging. If you want to read more on this matter, check the 1st and the 2nd part of our article regarding it.

TPD – Advertising and sales of tobacco products

As we mentioned earlier, TPD restricts the advertising of tobacco products in mass media to end consumers. Moreover, the promotion of e-cigarettes and refill containers is prohibited.

Make sure you read:

• Everything you should know about Tobacco Products Directive.
• Fees, Taxes And More: An Analysis Of Selected Regulations In Europe
• Excise Duty In The Vape Industry [Guide]
• TPD-Registration Process In Germany: What Do You Need To Know?
• Non-Nicotine E-Liquids And E-Cigarettes Must Be TPD Notified In Germany
• TPD In Poland

CLP stands for Classification, Labeling and Packaging. This legislation enforces manufacturers to properly communicate the dangers that stem from substances. An example of applying CLP guidelines is CLP pictograms, which show what dangers may result from the improper use of a substance.

However, these are just examples of CLP-imposed obligations. Others state that there must be a convex triangle on the bottle, to inform blind people about the dangers or a child-proof mechanism, so the youngest won’t spill or consume the substance.

If you want, learn more about:

• What CLP is and how it influences nicotine products
• CLP in 2024: key changes
• What Is UFI Code And How Does It Apply To The E-Liquid Industry?
• REACH: What Is Reach And Why We Talk About It?
• E-Liquid Bottles Nozzle Requirements
• Nicotine Shots: Dealing With TPD Regulations
• TPD Compliant E-Liquid Packaging: Part 1
• TPD Compliant E-Liquid Packaging: Part 2

Regulations In The Vape Industry: REACH

The last major legislation concerning e-liquids and other nicotine products is REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals.

REACH is one of the most important European regulations which applies to most chemical substances. According to REACH, manufacturers must identify and control the risks that come with substances manufactured and marketed in the European Union. It means they have to communicate how to safely use a substance and decrease the risk connected to its handling.

As for nicotine, due to REACH, companies handling chemicals in the amount above 1 ton annually must register chemicals at the European Chemicals Agency (ECHA). Consequently, substances are present in the system, which allows their faster identification, and their buyers are sure they come from a reliable source. Additionally, sales of pure nicotine, that hasn’t been registered, to the European market are illegal.

REACH registration procedure

As we mentioned, if a company handles above 1 ton of pure nicotine annually, they have to register it. The procedure of registration is a, so-called, “joint submission”, in cooperation with the Lead Registrant of the substance.

One can register their products on the REACH-IT website, using the IUCLID tool. To correctly execute the registration procedure, one must provide all the necessary data, especially regarding the hazardous properties of substances. After that, appropriate authorities evaluate the data, as ECHA has to authorize compounds of high concern, such as carcinogens or mutagens. All this ensures, that risks related to the use of such substances are adequately controlled or justified.

After successful registration, a product acquires a unique REACH Registration Number.

Transport regulations – ADR/IATA/IMDG