Italy’s parliament has passed a law implementing the EU ban on flavours in heated tobacco – but ambiguity in its definition of the category may lead to difficulties in interpretation, especially where health warning requirements are concerned.
Law No. 103/2023 adopts the European Commission Delegated Directive 2022/2100, which bans heated tobacco products (HTPs) with a characterising flavour and tobacco products containing flavourings in any of their components, as well as introduces further packaging restrictions.
The Italian law defines an HTP as “a novel tobacco product that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by the user(s) and that, due to its characteristics, is a smokeless tobacco product, as it is consumed without a combustion process”.
However, after initially categorising HTPs as smokeless, the law later introduces health warning and information message requirements for HTPs in an article dedicated to tobacco products for smoking.
This may create interpretation challenges with significant implications for implementing the law, particularly regarding labelling and health warning requirements.
Are HTPs smokeless under the law, or not?
TobaccoIntelligence legal analyst Lorenzo Guaragna said: “The additional packaging limitations introduced by the delegated directive will only be enforceable on HTPs when they are regarded as tobacco products intended for smoking.
“To eliminate any potential confusion in the interpretation of the law, it would have been prudent for the legislator to establish a distinct article exclusively addressing combined health warnings and informational messages for HTPs.”
A spokesperson for Italy’s Customs and Monopolies Agency (ADM) told TobaccoIntelligence that the revised definition of HTPs will impact labelling and packaging obligations for manufacturers, appearing to imply that the agency does indeed consider HTPs as tobacco products for smoking.
The spokesperson said: “These [obligations] include increased requirements for general warnings, informational messages, and combined health warnings like those used for traditional smoking tobacco products. The aim is to uphold consumer health protection standards, while the prohibition of characterising flavours for HTPs aims to bring consistency to the regulations governing these products, aligning them with the rules applied to cigarettes and rolling tobacco.”
The Italian requirement for informational messages and health warnings on tobacco products such as cigarettes was set out in Legislative Decree No. 6/2016.
‘The provisions don’t affect the classification’
A European Commission source told TobaccoIntelligence that HTPs can fall into two categories – smokeless tobacco products and tobacco products for smoking – and that it is up to EU member states to decide which one applies.
“The provisions of the delegated directive don’t affect the classification of heated tobacco products as either smokeless tobacco products or tobacco products for smoking,” the source said.
“Smokeless tobacco product” refers to tobacco products that are used without combustion, such as chewing tobacco, nasal tobacco and tobacco for oral use. This is consistent with the definition in article 2 of Directive 2014/40/EU, which has been updated by delegated directive 2022/2100.
Effective from 23rd October, the new Italian law also introduces transitional periods for non-compliant products: manufacturers can supply these to tax warehouses until 31st December 2023, tax warehouses can provide them to retailers until 1st March 2024, and retailers can sell existing stocks.
– Dario Sabaghi TobaccoIntelligence contributing writer
Photo: Mateus Campos Felipe