Requests Made to Subject E-Cigarettes to Technical Regulation

Requests Made to Subject E-Cigarettes to Technical Regulation


The Department for State Legislation at the Russian President’s Administration has indicated that some improvements to the restrictions on electronic cigarettes were required for a second reading of the bill. The State Duma is going to consider them in the second reading of the bill that regulates the trade of e-cigarettes.

On June 29, the Kremlin’s Department for State Legislation of the Kremlin made the reassessment of the bill and asked for removing the standards of technical regulation from it .

During preparations of the bill (Draft Federal Law No. 119575-7) for the second reading, more than 120 amendments completely changing the first version were made. For example, a proposal was proposed to fix the largest possible quantity of nicotine at 20 mg in one unit of the product. In addition, it suggested a complete ban on the sale of all nicotine-containing products as of 2023 if they do not meet safety requirements.

Not as per Technical Regulations

The Presidential Administration’s Department for State Legislation has already scrutinized the proposed amendments twice. The first review was sent to the State Duma on March 19, 2020. The experts working for the Administration pointed out that the proposed limit for the concentration of nicotine went beyond Federal Law No.15 and violated the technical regulation procedures for the goods of this kind in the Eurasian Economic Union. “In terms of establishing the maximum nicotine content in liquids for e-cigarettes, including the one in a purchasing unit of the products of this kind, all the relevant standards of technical regulation for nicotine-containing should be put in the relevant technical regulations,” said the agency.

Also, the experts of the Presidential Administration pointed out the need for separate regulations of production and sales of e-cigarettes, development of separate technical regulations for them and adoption of relevant amendments to other existing laws, for instance, to the Code of Administrative Offences and the Labour Code. In June, the authors of the amendments polished up the document and sent it to the Presidential Administration for a second review. On June 29, the new resolution was sent by the lawyers of the agency to the State Duma.

In a letter addressed to Dmitry Morozov, the head of the Healthcare Committee L.Brycheva, who is also an aide to Vlasimir Putin, says that “a significant number of notes are still relevant.” Thus, the comments of the legislative department “on the definition of technical requirements to nicotine-containing products in the legislation on the specialized technical regulation,” and “on the differentiated approach to production regulations, turnover and sales in compliance with the legislation of the Russian Federation on the protection of consumers’ rights for technically complex and expensive innovative e-cigarettes in comparison with technologically primitive tobacco products” have not been taken into account,” the department said.

According to the agency, the bill needs to be improved in connection with the abovementioned remarks.

In its analysis of the bill, the Russian Union of Industrialists and Entrepreneurs also says that it is necessary to substantiate technical requirements for e-cigarettes in technical regulations and not within the framework of the so-called “anti-tobacco law.” Apart from the characteristics of the composition of e-cigarettes the confidence interval should be taken into account and the methods of measuring these indicators should be approved, says the analytical note the Union of Industrialists and Entrepreneurs sent to the Department for State Legislation. All this should be applied not only on the territory of Russia, but also on the Customs Union. The department supported this initiative. The State Duma was recommended to take into account the notes of the Russian Union of Industrialists and Entrepreneurs, otherwise there might be difficulties with formulating the technical regulations of the Eurasian Economic Union. So, chances are the restrictive measures will not work. According to sources in the State Duma, the version of the bill that was finalized in accordance with these comments, is likely to go through another stage of approvals with the Department for State Legislation before it is submitted for consideration in the run-up to the second reading.

Controversial Milligrams

The regulation of nicotine content in e-cigarettes at 20 mg/ml proposed by the bill’s authors repeats the European Technical Regulations introduced in 2014. This regulation is not valid in other parts of the world. In June, the issue of how much nicotine should there be in e-cigarettes came into spotlight of the scientific workshop “Specifics of nicotine products – a view of world science” organized by the Institute of Regional Problems. David Zaridze, the President of the Russian Anticancer Association and Doctor of Medical Sciences, Eugenia Gnuchikh, the deputy director for research and innovations of the All-Russia Research Institute of Tobacco and Tobacco Products, Pr.Konstantinos Farsalinos, the author of more than 90 international studies on e-cigarettes and the health problems caused by smoking, who took part in the work on the European technical regulation, shared their opinion on the issue.

According to Pr. Farsalinos, when imposing restrictions on nicotine yield in e-cigarettes, the European officials misinterpreted his study and relied on the actual consumption of liquids. So, the data on the absorption of nicotine in the consumer’s body were not taken into account. Due to the difference in heating temperature and product properties, this indicator is several times different from regular cigarettes.

“With 20 mg/ml nicotine content in the liquid, the consumer actually gets 4 times less nicotine than when smoking a regular cigarette,” says Farsalinos. “This limit does not allow the smoker to fully switch to e-cigarette.”

“Three years after the adoption of the EU technical regulation, the World Health Organization issued a report saying that e-cigarettes should be able to compensate the smokers’ need for nicotine. According to Farsalinos, 60 mg/ml nicotine in liquid is more effective in terms of smoking cessation. Weak nicotine in e-cigarettes has a disadvantage. Farsalinos says that consumers begin to “vape” more liquide, absorbing more of the side components of the aerosol. His viewpoint was supported by Alexander Myasnikov, the well-known Russian cardiologist, who said that electronic cigarettes were not harmless, but less harmful than regular cigarettes and they could help smokers give up smoking quickly. “But there should be enough nicotine in them,” Dr. Myasnikov wrote in his Telegram channel.

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