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Tobacco e-cigarettes


Nicotine (CAS 54-11-5, EC 200-193-3)
Nicotine is regulated by Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals. Nicotine is included in Annex I, Part 2, of this regulation, in connection with banning of her using in pesticides in EU. Regarding to Regulation 649/2012 export of chemicals, mentioned in Annex I, outside of EU must be preceded by an export to the designated authority in the exporting country. In case of import of chemicals, there is no need to inform competent authority about import of chemicals to EU, but Regulation 649/2012 obligate importers to provide the  competent authority with an annual report regarding the quantity of these chemicals. This provision is in force irrespective of planned category of application of imported chemicals. More information
Irrespective of Regulation 649/2012, placing on the market nicotine is also regulated by the act of 25 February 2011 on the Chemical Substances and Their Mixtures (Journal of Laws of 2011, No. 63, item 322), Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (in particular article 6 concerning obligation of registration) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006. Regarding to CLP, labeling of nicotine placing in the Polish market should be done in Polish language.
What is more, when liquids containing nicotine are classified as dangerous/hazardous mixtures, information about their import (or production) together with the safety data sheet of the mixture should be submitted to Inspector for Chemical Substances on the base of article 15 the act of 25 February 2011 on the Chemical Substances and Their Mixtures (Journal of Laws of 2011, No. 63, item 322). More information about this procedure of submitting/informing.
Furthermore, please pay attention to changes in the classification and labelling of nicotine. The new harmonized classification of nicotine was applied by Commission Regulation (EU) 2017/776 of 4 May 2017 since 1st December 2018. Acute Toxicity Estimates (ATE) were included to Part 3 of Annex VI to Regulation (EC) No 1272/2008 in order to facilitate the harmonisation of the classification of mixtures as regards acute toxicity respectively for the three routes of exposure.
Harmonized classification of  nicotine up to 30th November 2018:
  Classification  Labelling

Acute Tox. 1; H310


Acute Tox. 3 (*); H301


Aquatic Chronic 2; H411



GHS06; GHS09, Dgr


Harmonized classification of  nicotine obligatorily since 1st December 2018 (substances and mixtures might be classified from May 2017):

  Classification Labelling ATE Values

Acute Tox. 2; H330

H330 inhalation: ATE = 0,19 mg/L (dusts and mists)
Acute Tox. 2; H310 H310

dermal: ATE = 70 mg/kg

Acute Tox. 2; H300 H300

oral: ATE = 5 mg/kg

Aquatic Chronic 2; H411 H411  

GHS06, GHS09, Dgr


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