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Public Health (22-07-2016)

Public consultation on the preliminary Opinion on additives used in tobacco products (Tobacco Additives II)

SCHEER's Preliminary Opinion on additives used in tobacco products (Tobacco Additives II), published today for public consultation, aims to develop guidelines for types of studies and their criteria that should be requested by manufacturers to assess the relevance of the individual additives and the most suitable methodologies to be used.

It outlines studies for a priority list of 15 additives and for additives that may be added to the list in the future and also provides a reporting template.

Interested parties are invited to submit comments about relevant scientific evidence online before 22 september 2016.

Background

This is the second of two Opinions on additives used in tobacco products.

Stemming from Tobacco Products Directive 2014/40/EU and from a previous SCENIHR Opinion (Tobacco Additives I), the Commission has established a priority list of 15 additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations 1 that is to be updated on a regular basis.

Manufacturers and importers of tobacco products must carry out comprehensive studies on the additives included in the priority list. In the second Opinion (Tobacco Additives II), the SCHEER was asked to provide guidance on the type and criteria for these comprehensive studies, and the most suitable methodologies to be used for the first list of 15 priority additives and for future updated lists.

To minimise testing, the SCHEER proposes a step-wise strategy as the most pragmatic and efficient way to proceed in the assessment of the toxic and addictive effects and characterising flavour properties. 

In addition, the SCHEER analysed major data gaps for the 15 additives included in the priority list of additives, which mainly concern information on addictiveness and attractiveness and on the identity of the pyrolysis products.

More information


1 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016D0787&from=EN