Nicotine pouches must comply with specific requirements in order to be marketed. The applicable regulations are continuously evolving, as this type of product has only recently been introduced to the market and may be subject to changes, potentially significant ones.

TRUSTiCERT offers consulting services to support companies in the marketing of nicotine pouches in Italy and closely monitors regulatory developments through direct contact with the competent authorities.

Each nicotine pouch package must meet safety and chemical requirements, in addition to fulfilling the obligations imposed by the General Product Safety Regulation, Regulation (EC) No. 1272/2008 (CLP), and Regulation (EC) No. 1907/2006 (REACH) regarding labelling, preparation of Safety Data Sheets (SDS), and potential PCN notification / UFI code placement.

Although nicotine pouches are not currently included in the Tobacco Products Directive (2014/40/EU), the Customs and Monopolies Agency (ADM) has extended some TPD labelling obligations to these products (e.g., ingredient list, health warning, etc.).

TRUSTiCERT can support nicotine pouch manufacturers and importers with:

• Preparation of Safety Data Sheets (SDS)
• Creation of UFI code and PCN notification
• Regulatory and graphic compliant labelling
• Environmental labelling for packaging

The SDS is a legally binding document that the supplier of a hazardous substance or mixture (manufacturer/importer/responsible company) is required to provide to the final user when the final user is a professional user.
To ensure the confidentiality of your trade secrets, we create the SDS internally through our experts, without relying on third-party providers. The SDS are prepared based on the formula of each product variant and according to the regulations and language of the destination country.

The UFI code is a mandatory element on the labels of hazardous mixtures. UFI stands for Unique Formula Identifier; it is a 16-character alphanumeric code that uniquely identifies a mixture at the European level and links it to the specific information provided via harmonised PCN notification.

The Directive (EU) 2018/851 and its national transposition have made environmental labelling on packaging mandatory in Italy to provide information on the correct disposal of packaging. This Directive has also been adopted in some European states that require disposal information for packaging to be included on labels. These details must be provided in accordance with the legislation in force in the country where the packaged products are sold.