TPD Labels: 5-Step Verification

When a product arrives in the store or is about to be sold online, the label is the first check to perform. The TPD (Directive 2014/40/EU, Art. 20) establishes precise rules for the presentation and information to consumers about e-cigarettes and refill containers; these rules complement the CLP regulations on classification, labeling, and packaging of mixtures for chemical safety aspects. In Italy, ADM requirements on warnings and legitimacy marks are also added. A well-structured, repeatable, and documented check before display (“pre-shelf”) significantly reduces risks.

Step 1 — Health Warning and Print Surfaces

For products covered by Art. 20 TPD, the packaging must display a text health warning dedicated to e-cigs, with the dimensions and placement required by the directive (a warning that, in application practice, covers at least 30% of the two main surfaces of the outer package). The Commission clearly summarizes the obligation: packages must warn that the product contains nicotine and is not intended for non-smokers, in addition to prohibiting promotional elements on the packaging. In Italy, national regulations detail the text and graphic rendering of the warning and periodically update operational guidelines. Make sure the warning is clearly legible in Italian and consistent with the most recent ministerial guidelines.

Step 2 — Information Leaflet, Ingredients, and Nicotine

Inside the package, there must be an information leaflet with usage instructions, information about at-risk groups, toxicity, and addictiveness, along with the ingredients list and the indication of nicotine content on the outer pack. These requirements derive directly from Art. 20 TPD and are summarized on the Commission’s pages dedicated to e-cigs. In the absence of the leaflet or if the ingredients are not clearly indicated, the product should not be displayed, and the compliant version should be requested from the supplier.

Step 3 — CLP-Compliant Pictograms and Hazard Statements

When the liquid falls within the scope of CLP (Reg. 1272/2008), hazard pictograms must be diamond-shaped (rotated square), with a red border, black symbol on a white background, with adequate contrast and legibility. Compliance with graphic specifications is not an aesthetic detail: it is part of the legal obligations regarding information on the hazards of mixtures. In case of doubt about the classification (e.g., flammable aerosols, sensitizers, etc.), compare the label with the SDS and verify the consistency between pictograms, hazard statements (H), and precautionary statements (P).

Step 4 — Prohibited Elements and Communication Consistency

The packaging must not contain promotional elements or texts intended to mislead: no claims about benefits, no suggestions of risk reduction, or other messages that could enhance the product beyond mandatory information. This approach is expressly referenced by the Commission for e-cigs and adopted in ADM labeling practices: the pack-leaflet combination must inform without promoting. Also maintain consistency between what appears on the packaging, the online product sheet, and in-store materials: any discrepancies would expose the retail point to findings during inspections.

Step 5 — National Requirements: ADM Marks and Layout

In Italy, in addition to European requirements, packaging must comply with the legitimacy marks and warnings established by ADM. Directorial determinations set the methods, colors, and application at packaging closure; from September 1, 2024, the use of the gray mark was introduced on individual packages of inhalation products, with graphic and operational specifications. Circulars also clarify that the layout of warnings (font, border, placement, surface percentages) must follow official guidelines; in case of a non-compliant batch, the solution is not to “adapt” in the store, but to suspend display and request correctly marked and warned packaging from the supplier.

Your Operational “Pre-Shelf” Checklist

Before display, check that the health warning is present and correctly sized on the two main surfaces, that ingredients and nicotine are clearly indicated, that the leaflet is actually included, that any CLP pictograms are compliant, and that ADM marks/warnings are intact and properly positioned. Record the date, result, and operator on a brief internal log and keep the SDS on file (digital + paper) available to staff. If something doesn’t add up, put the product on hold, open a ticket with the supplier, and document the non-compliance.