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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">toxreview</journal-id><journal-title-group><journal-title xml:lang="ru">Токсикологический вестник</journal-title><trans-title-group xml:lang="en"><trans-title>Toxicological Review</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0869-7922</issn><issn pub-type="epub">3034-4611</issn><publisher><publisher-name>Federal Scientific Center of Hygiene named after F.F. Erisman</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.47470/0869-7922-2023-31-2-72-82</article-id><article-id custom-type="elpub" pub-id-type="custom">toxreview-687</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Обзор законодательного регулирования производства и оборота электронных систем доставки никотина и предложения по актуализации технического регулирования</article-title><trans-title-group xml:lang="en"><trans-title>Overview of the legislative regulation of the production and circulation of electronic nicotine delivery systems and a proposal for updating technical regulation</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Скворцова</surname><given-names>Екатерина Львовна</given-names></name><name name-style="western" xml:lang="en"><surname>Skvortsova</surname><given-names>Ekaterina Lvovna</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кандидат мед. наук, заведующий отделом профилактической токсикологии и санитарно-эпидемиологической экспертизы непродовольственной продукции ФБУЗ «Центр гигиены и эпидемиологии в городе Москве», 129626, г. Москва.</p><p>e-mail: opt_skvortsova@mail.ru</p></bio><bio xml:lang="en"><p>Candidate of Medical Sciences, Head of the Department of Preventive Toxicology and Sanitary and Epidemiological Expertise of Non-Food Products, Federal Budget Health Institution "Center for Hygiene and Epidemiology in Moscow", 129626, Moscow, Russian Federation.</p><p>e-mail: opt_skvortsova@mail.ru</p></bio><email xlink:type="simple">opt_skvortsova@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Морозова</surname><given-names>Инна Александровна</given-names></name><name name-style="western" xml:lang="en"><surname>Morozova</surname><given-names>Inna Alexandrovna</given-names></name></name-alternatives><bio xml:lang="ru"><p>Врач по общей гигиене, заведующий отделением санитарно-эпидемиологической и токсикологической экспертизы отдела профилактической токсикологии и санитарно-эпидемиологической экспертизы непродовольственной продукции ФБУЗ «Центр гигиены и эпидемиологии в городе Москве», 129626, г. Москва.</p><p>e-mail: opt_morozova@mail.ru</p></bio><bio xml:lang="en"><p>doctor for general hygiene, head of the department of sanitary-epidemiological and toxicological examination of the department of preventive toxicology and sanitary-epidemiological examination of non-food products Federal Budget Health Institution "Center for Hygiene and Epidemiology in Moscow", 129626, Moscow, Russian Federation.</p><p>e-mail: opt_morozova@mail.ru</p></bio><email xlink:type="simple">opt_morozova@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФБУЗ «Центр гигиены и эпидемиологии в городе Москве»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal Budget Health Institution "Center for Hygiene and Epidemiology in Moscow"</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>27</day><month>04</month><year>2023</year></pub-date><volume>31</volume><issue>2</issue><fpage>72</fpage><lpage>82</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Скворцова Е.Л., Морозова И.А., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Скворцова Е.Л., Морозова И.А.</copyright-holder><copyright-holder xml:lang="en">Skvortsova E.L., Morozova I.A.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.toxreview.ru/jour/article/view/687">https://www.toxreview.ru/jour/article/view/687</self-uri><abstract><p>В данной работе представлен обзор законодательного и технического регулирования за производством, продвижением, оборотом и потреблением никотинсодержащей продукции (электронных систем доставки никотина, вейпов, электронных сигарет, бестабачных курительных смесей). актуальность в изучении вопроса вызвана отмечающимся ростом распространения и потребления данной продукции среди населения Российской Федерации, особую озабоченность вызывает её распространение среди детей и молодежи. Потенциальная опасность и токсический риск вызван воздействием никотина, а также гликолей, глицеролов, альдегидов (в том числе формальдегида), летучих органических веществ, полициклических ароматических углеводородов, дикарбонилов, гидроксикарбонилов (ацетола), металлов, частиц силиката и других элементов, находящихся в аэрозоле при вдыхании. </p><p>Приведён сравнительный анализ международного опыта и практики установления и применения требований безопасности к никотиносодержащей продукции, а также анализ нормативных правовых и нормативно-технических актов государств-членов Евразийского экономического союза в области регулирования никотиносодержащей продукции. </p><p>В результате был сделан вывод о чрезвычайно высокой актуальности разработки, утверждения и внедрения в рамках Евразийского экономического союза законодательного технического регулирования — технического регламента ЕАЭС «Технический регламент на никотинсодержащую продукцию», межгосударственных стандартов, содержащих правила и методы исследований (испытаний) и измерений, в том числе правила отбора образцов никотиносодержащей продукции как отдельной категории продукции, которая может нести потенциальный риск для здоровья потребителей.</p><sec><title>Участие авторов</title><p>Участие авторов. Все соавторы внесли равнозначный вклад в исследование и подготовку статьи к публикации.</p></sec><sec><title>Конфликт интересов</title><p>Конфликт интересов. Авторы заявляют об отсутствии конфликта интересов.</p></sec><sec><title>Финансирование</title><p>Финансирование. Исследование не имело спонсорской поддержки.</p></sec><sec><title>Поступила в редакцию</title><p>Поступила в редакцию: 10 марта 2023 / Принята в печать: 29 марта 2023 / Опубликована: 30 апреля 2023</p></sec></abstract><trans-abstract xml:lang="en"><p>This paper provides an overview of the legislative and technical regulation of the production, promotion, circulation and consumption of nicotine-containing products (electronic nicotine delivery systems, vapes, electronic cigarettes, non-tobacco smoking mixtures), the relevance in studying the issue is caused by the observed increase in the distribution and consumption of these products among the population of the Russian Federation. The spread among children and young people is of particular concern. The potential danger and toxic risk is caused by exposure to nicotine, as well as glycols, glycerols, aldehydes (including formaldehyde), volatile organic substances, polycyclic aromatic hydrocarbons, dicarbonyls, hydroxycarbonyls (acetol), metals, silicate particles and other elements found in aerosol by inhalation. A comparative analysis of international experience and practice of establishing and applying safety requirements for nicotine-containing products, as well as an analysis of regulatory legal and regulatory and technical acts of the member states of the Eurasian Economic Union in the field of regulation of nicotine-containing products is given.</p><p>As a result of the work, it was concluded that the development, approval and implementation of legislative technical regulation within the framework of the Eurasian Economic Union — the technical regulation of the EAEU "Technical regulation for nicotine-containing products", interstate standards containing rules and methods of research (testing) and measurements, including the rules for sampling nicotine-containing products as a separate category of products that may carry a potential risk to the health of consumers.</p><sec><title>Contribution</title><p>Contribution. All authors made an equal contribution to the preparation of the article for publication.</p></sec><sec><title>Conflict of interest</title><p>Conflict of interest. The authors declare no conflict of interest.</p></sec><sec><title>Funding</title><p>Funding. The study was not sponsored.</p></sec><sec><title>Received</title><p>Received: March 10, 2023 / Accepted: March 29, 2023 / Published: April 30, 2023</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>электронные системы доставки никотина (ЭСДН)</kwd><kwd>никотиносодержащая продукция</kwd><kwd>вейп</kwd><kwd>POD System Vape (Pod-системы)</kwd><kwd>электронная сигарета</kwd><kwd>электронный кальян</kwd><kwd>жидкость для электронных систем доставки никотина</kwd><kwd>жидкость для заправки вейпов</kwd><kwd>бестабачные курительные смеси</kwd></kwd-group><kwd-group xml:lang="en"><kwd>electronic nicotine delivery systems (ENDS)</kwd><kwd>nicotine-containing products</kwd><kwd>vape</kwd><kwd>POD System Vape (Pod systems)</kwd><kwd>Electronic Cigarette</kwd><kwd>electronic hookah</kwd><kwd>liquid for electronic nicotine delivery systems</kwd><kwd>liquid for refilling vapes</kwd><kwd>non-tobacco smoking blends</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Указ Президента Российской Федерации от 07.05.2018 № 204 (ред. от 21.07.2020) «О национальных целях и стратегических задачах развития Российской Федерации на период до 2024 года». 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Art. 20, paragraph 4 Legislative decree 12 January 2016, No. 6: Transposition of Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States relating to the processing, presentation and sale of tobacco products and related products and repealing Directive 2001/37/EC. (16G00009). Gazzetta Ufficiale, No. 13 of 18 January 2016. URL: https://d3vqfzrrx1ccvd.cloudfront.net/uploads/legislation/Italy/Italy-Legislative-Decree-No.-6-of-Jan.-12-2016-national.pdf (in italiano) (accessed 07.03.2023)</mixed-citation><mixed-citation xml:lang="en">Maximum levels of tar, nicotine emissions and carbon monoxide and other substances. 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Art. 3, paragraph 1 Legislative decree 12 January 2016, No. 6: Transposition of Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States relating to the processing, presentation and sale of tobacco products and related products and repealing Directive 2001/37/EC. (16G00009). Gazzetta Ufficiale, No. 13 of 18 January 2016. URL: https://d3vqfzrrx1ccvd.cloudfront.net/uploads/legislation/Italy/Italy-Legislative-Decree-No.-6-of-Jan.-12-2016-national.pdf (in italiano) (accessed 07.03.2023)</mixed-citation><mixed-citation xml:lang="en">Decree of the Government of the Russian Federation No. 224 dated February 28, 2019 (ed. dated 11/30/2022) “On approval of the Rules for Labeling tobacco, nicotine-containing and nicotine-free products by means of identification and the specifics of the implementation of the State information system for Monitoring the turnover of goods subject to mandatory labeling by means of identification in relation to tobacco, nicotine-containing and nicotine-free products” (with amendments. and the additions made by the Decree of the Government of the Russian Federation dated November 30, 2022 No. 2178, intro. effective from 01.03.2023). Access from the ConsultantPlus legal reference system. https://www.consultant.ru/document/cons_doc_LAW_319565/ (in Russian) (accessed 07.03.2023)</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Постановление Правительства РФ от 28 февраля 2019 г. № 224 (ред. от 30.11.2022) «Об утверждении Правил маркировки табачной, никотинсодержащей и безникотиновой продукции средствами идентификации и особенностях внедрения государственной информационной системы мониторинга за оборотом товаров, подлежащих обязательной маркировке средствами идентификации, в отношении табачной, никотинсодержащей и безникотиновой продукции» (с изм. и доп., внесёнными Постановлением Правительства РФ от 30 ноября 2022 г. № 2178, вступ. в силу с 01.03.2023). Доступно в справочно-правовой системе «КонсультантПлюс». https://www.consultant.ru/document/cons_doc_LAW_319565/ (дата обращения 07.03.2023)</mixed-citation><mixed-citation xml:lang="en">Постановление Правительства РФ от 28 февраля 2019 г. № 224 (ред. от 30.11.2022) «Об утверждении Правил маркировки табачной, никотинсодержащей и безникотиновой продукции средствами идентификации и особенностях внедрения государственной информационной системы мониторинга за оборотом товаров, подлежащих обязательной маркировке средствами идентификации, в отношении табачной, никотинсодержащей и безникотиновой продукции» (с изм. и доп., внесёнными Постановлением Правительства РФ от 30 ноября 2022 г. № 2178, вступ. в силу с 01.03.2023). Доступно в справочно-правовой системе «КонсультантПлюс». https://www.consultant.ru/document/cons_doc_LAW_319565/ (дата обращения 07.03.2023)</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
