Eurasian Economic Union Publishes Draft Regulations on Nicotine Products

On August 11th, the Eurasian Economic Union announced a draft technical regulation (TR EAEU/20) on nicotine-containing products, including nicotine e-cigarettes (both with and without nicotine) and requirements for the content and information of substances in aerosols delivered through nicotine delivery systems. The regulation sets unified mandatory requirements for application and enforcement within the Union Customs Territory. It also outlines packaging requirements, compliance assessment forms, identification rules, labeling requirements, and usage rules to ensure the free circulation of nicotine-containing products within the Union. Starting from September 5th to November 30th, there will be an 86-day public discussion on the draft regulation before a final decision is made.

Translation: Rules for Product Circulation.

a. Nicotine products can only be sold in member countries of the union if they meet the requirements of TR EAEU/20 technical regulations. b. They must also meet other technical regulations set by the union and be marked with a single compliance symbol in order to be circulated in member countries' markets. c. Additionally, the product's suitability must be confirmed before it can be marked with the single circulation symbol and sold in the union's markets. Products that have not been confirmed as suitable are not permitted to be sold in the union's markets nor can they be released to the market.

Product identification rules stipulate that nicotine consumption devices can be categorized as either disposable or reusable (open or closed system) devices based on product design. Disposable devices are nicotine delivery systems that are pre-filled and designed for single use, while open system devices are reusable and contain a container that can be refilled once the filling material is consumed. Depending on the filling material, open systems can be liquid-based or tobacco/non-tobacco mixed based. Closed systems are also reusable but designed for consuming e-liquids with or without nicotine. Nicotine consumption devices can be further categorized based on the type of filling material as liquid-based, tobacco/non-tobacco mixed based or a combination of both. Closed systems can be used for consuming nicotine/non-nicotine liquid or heated tobacco products, including non-standard mixes designed for heating.

Product compliance requirements include: a) when producing nicotine-containing products, it is not allowed to use substances prohibited by international treaties of member states or substances listed in Appendix 2 of TR EAEU/20; b) when producing nicotine-containing products, the use of glycerol, propylene glycol, and nicotine is permitted, but their raw material purity must not be less than 94wt%, 95wt%, and 99wt%, respectively; c) the nicotine concentration in liquid mixtures should not exceed 20mg/mL; d) the volume of liquid mixture in disposable nicotine-containing products must not exceed 2mL; e) the volume of liquid mixture storage containers must not exceed 10mL; f) the substance content in 100 cubic centimeters of aerosol generated during the use of nicotine products (excluding tobacco and non-standard mixtures for heating) must not exceed the limit values given in the table.

The TR Appendix 2 specifies a list of prohibited substances which includes agar, vitamin E acetate, birch tar, diacetyl, diethylene glycol, bitter almond oil containing free or bound cyanide, camphor oil, juniper berry oil, camphor, coumarin, saffron, and ethylene glycol. These substances/components/specific plants are not allowed to be used in the production of nicotine-containing products.

Introduction to the Eurasian Economic Union.

The Eurasian Economic Union (EAEU), also known as the Eurasian Economic Commission, was established in 2015. Its member countries currently include Russia, Kazakhstan, Belarus, Kyrgyzstan, and Armenia, all of which are important partners in the "Belt and Road" initiative. The union aims to achieve free flow of goods, services, capital, and labor within the union by 2025, and to implement coordinated economic policies.

According to some reports, Russia - a major member state of the Eurasian Economic Union (EAEU) - believes that regulation of new tobacco products is necessary, and the recently announced TR EAEU/20 confirms that the EAEU has established a preliminary regulatory framework for the control of new tobacco products. Companies interested in exporting to this market should closely monitor the progress of regulatory development and implementation in order to ensure that their products comply and can be exported smoothly.

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