In brief

On 11 November 2022, the Ministry of Ecological Transition (Ministry) answered the Confindustria’s question on whether the packaging of medicines for human use, medical devices and in-vitro diagnostic medical devices must comply with the environmental labelling requirements set forth in Article 219, Section 5, of Legislative Decree 152/2006, starting from 1 January 2023.

Key takeaways

According to said requirements, all packaging of products placed on the Italian market must be appropriately labelled so as to provide information on the nature of the packaging materials used. In addition, packaging intended for final consumers must also indicate the relevant details to facilitate its collection, reuse, recovery and recycling.

In this regard, the Ministry stated that the provisions on environmental labelling do not apply to the packaging of the products at issue until the adoption of the decree referred to in Article 219, Section 4, which will establish the specific technical measures for these products. Indeed, the mentioned Section 4 states that, for the packaging of medical equipment and pharmaceutical products, the specific technical measures to comply with environmental labelling requirements will be established by a decree issued by the Ministry in agreement with the Ministry of Health, which has not yet been adopted.

There are still some uncertainties as to the actual scope of the above-mentioned exclusion. Indeed, Section 4 of Article 219 expressly covers primary packaging only, while the response provided by the Ministry makes no distinction between primary packaging and secondary and/or tertiary packaging which, based on a literal interpretation of the rule, should therefore comply with environmental labelling requirements starting from 1 January 2023.