The Italian Ministry of Health has issued new operational guidance on misleading terms in the labelling and trade names of biocidal products and medical-surgical devices (presidi medico-chirurgici, PMCs).
The document provides further clarification on the criteria to be considered to ensure that trade names, text, images and graphic elements do not mislead consumers regarding the nature, characteristics, efficacy or conditions of use of these products.
Trade names and misleading terms: key considerations
Among the issues highlighted by the Ministry is the use of terms that may imply characteristics that have not been adequately substantiated or may lead consumers to perceive a product as belonging to a different category, such as cosmetics, detergents, medicinal products or medical devices.
The list of terms considered misleading in trade names includes, among others, “bio”, “natural”, “organic”, “eco”, “ecological”, “green” and “safe”, subject to the specific exceptions set out in the document. The guidance also addresses promotional claims appearing on product labels. Statements relating to product safety, efficacy or performance must be assessed with particular care and must be consistent with the authorised conditions of use and, where required, supported by appropriate documentation.
Particular attention to graphics and images
The new guidance emphasises that label compliance is not limited to textual content. Images, symbols and graphic elements must also be consistent with the product’s authorised intended use. The trade name must be clearly identifiable, and images must not compromise the legibility of the information displayed on the packaging.
The document also highlights the requirement for the trade name appearing on the label to match the name specified in the applicable authorisation documentation.
What are the implications for companies?
The guidance is relevant to operators involved in the marketing of biocidal products and medical-surgical devices (PMCs), particularly with regard to the review of labels, trade names and commercial communications.
The document reiterates that products must be placed on the market in compliance with their authorised conditions of use. Advertising and information intended for consumers must also be consistent with the authorisation and must not imply levels of safety or efficacy, or uses, that have not been authorised.
The list of terms included in the guidance is non-exhaustive and may be updated. It is therefore important to consult the most recent version of the applicable documentation and follow the guidance issued by the competent authorities.
Bio Chem S.r.l. closely monitors regulatory developments affecting the chemical and regulatory affairs sectors, with the aim of contributing to the dissemination of clear, up-to-date information for industry professionals.
Source: Italian Ministry of Health, Operational Guidance on Misleading Elements in the Labelling of Biocidal Products and Medical-Surgical Devices Placed on the Market, October 2026.