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In brief

On 29 November 2021, Legislative Decree No. 179/2021 was published in the Official Journal, introducing the applicable sanctions for violations of Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products (“Regulation“). The new sanctions entered into force on 14 December 2021.

In particular, Legislative Decree No. 179/2021 introduces sanctions for different types of violations, including the making available on the market of biocidal products without the prescribed authorization or on the basis of an invalid or revoked authorization; the breach of classification, packaging and labeling rules; the violation of advertising prohibitions; the failure to provide information required for the performance of checks aimed at ensuring compliance of biocidal products with the requirements provided for by the Regulation; as well as sanctions for the violation of the rules governing the marketing and manufacturing of medical-surgical aids laid down in Presidential Decree No. 392/1998.

Applicable sanctions include administrative pecuniary fines and detention. Administrative sanctions are assessed and applied by the region or autonomous province in whose territory the violation is committed or by the body identified by the relevant regional legislation.


Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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