The standard GOST R 58109-2018 formulated by Russia, a member state of the Eurasian Economic Union (EAEU), was adopted as the technical specification for e-cigarette products by the Union’s draft “Technical Regulations on Nicotine-Containing Products” in August this year.
Product Specifications
The standards required for the application and implementation of the Eurasian Economic Union “Technical Regulations on Nicotine-Containing Products” include 3 Russian national standards and 1 ISO standard, as follows:
a. GOST R 58109-2018 “General Technical Specifications for Electronic Nicotine Delivery System Liquids”;
b. GOST R 57458-2017 “General Technical Specifications for Heated Tobacco Products”;
c. GOST R ** “General technical specifications for non-packaged nicotine-containing oral products” (the standard is still under development);
d. GOST ISO 8317-2019 “Child-resistant packaging Requirements and test procedures for repackaged items”.
Scope of application and basic requirements
a. Scope of application: GOST R 58109-2018 applies to electronic nicotine delivery system (ESDN) liquids, but not to ESDN liquids containing tobacco or related to drugs;
b. Basic requirements: ESDN liquid manufacturers must comply with the standard requirements for the manufacture of specific product technical instructions and formulas, and comply with the safety requirements stipulated in the normative legal documents of the Russian Federation.
Raw material requirements
Raw materials used in the manufacture of ESDN liquids shall comply with
a. Nicotine or nicotine salt, with a purity of not less than 98%;
b. Propylene glycol, with a purity of not less than 95%;
c. Glycerol, with a purity of not less than 94%;
d. Other ingredients that are allowed to be used to ensure that the ESDN liquid meets the characteristics defined by the manufacturer.
Basic Packaging Requirements
a. ESDN liquids are subpackaged, bottled or directly prefilled into electronic cigarette devices by the manufacturer in an industrial manner;
b. The liquid storage bottle should meet the requirements of GOST ISO 8317 to ensure that it cannot be opened by children;
c. Partial packaging, liquid storage bottles and electronic cigarettes filled with ESDN liquids in an industrial manner shall ensure that no liquid leaks;
d. The manufacturer shall determine the list and evaluation method of possible visual defects in sub-packages, liquid storage bottles and consumer packaging.
Packaging Material Requirements
Batch packs, bottles and consumer packs of the product should use
a. Carton labels in accordance with GOST 7933;
b. Cartons, paper and composite materials in accordance with GOST 33781;
c. Flat cardboard for packaging in accordance with GOST 9421;
d. Packaging paper conforming to GOST 8273;
e. Polymer films in accordance with GOST 26996;
f. Polymer consumer packaging in accordance with GOST 33756;
g. To ensure product safety, other packaging materials including imported packaging materials are also allowed.
Consumer Packaging Requirements
Consumer packages of ESDN liquids should be marked
a. Product type, name, unit quantity (for bulk-packed products), name and address of the manufacturer, name and address of an organization registered in the territory of the Russian Federation to accept consumer claims or an authorized manufacturer;
b. ESDN liquid volume (in cm3) and nicotine content in the liquid (in mg/cm3);
c. Instructions in compliance with the standard GOST R 58109-2018;
d. Production date (year, month);
e. Marking: “Prohibition to sell to minors”, “Keep out of reach of children”, etc.;
f. Warning: “nicotine addictive” (for liquids containing nicotine), written in black capital letters on a white background;
g. If the above information cannot be printed on the consumer product packaging, the information shall be in the information leaflet contained in the consumer product packaging;
h. The listed information shall be written in Russian, and the content of the registered trademark or design shall be in the registered language.
Shipping Packaging Requirements
The transport package of ESDN liquid should be marked
a. Product type, name, manufacturer’s name and address, product quantity information (for bulk-packed products), and the total amount of liquid contained in the consumer package in the transport package;
b. Other reliable information may be attached to the shipping package;
c. The transportation package and accessories should be tightly sealed to ensure the safety of the product during transportation and storage.
Storage requirements
a. Products are transported by various modes of transport in accordance with the cargo transport rules applicable to the mode of transport;
b. The transport packaging of the products loaded in the means of transport must be stacked in such a way that the bottom drawer does not deform;
c. When stacking for storage, the shape of the stack should prevent deformation of the bottom layer;
d. The manufacturer may also specify additional requirements for the storage and transportation of the product.
Russia, a major member of the EAEU, believes that the regulation of new tobacco products is imperative. The TR EAEU/20 draft and related product technical specifications announced this time also confirm that the Eurasian Economic Union has initially established a control system for new tobacco products. Relevant companies interested in the economic zone market can pay close attention to the progress of legal
