07 December 2021
Chemicals compliance
The Legislative Decree No 179 of 2 November 2021 has been published, containing the Sanctions Regulation for the infringement of the provisions of Regulation (EU) No 528/2012 on biocidal products. The decree also contains the sanctions for medical surgical devices.
This decree illustrates the sanctioning discipline provided for both criminal and administrative offences.
The following offences are considered criminal offences:
- The placing on the market of an unauthorised biocidal product, or under an authorisation which is no longer valid or which has been revoked, or for the professional or industrial user using an unauthorised biocidal product or in breach of the conditions of use specified in the authorisation;
- For making a biocidal product available on the market in contravention of the provisional measures taken pursuant to Article 88;
- For placing on the market or professional or industrial use of a medical surgical device in the absence of the authorisation referred to in Article 2 of Presidential Decree 392/98 or in breach of the conditions laid down in that authorisation, or for manufacturing medical surgical devices in the absence of the authorisation referred to in Article 3 of Presidential Decree 392/98.
Articles 7 and 13 of the legislative decree, on the other hand, introduce pecuniary administrative sanctions for the violation of certain provisions of the European Regulation, such as
- violations concerning the placing on the market of treated articles
- violations concerning registration and reporting
- breaches of advertising obligations
- breaches of transitional measures concerning access to the active substance dossier
- breaches of control obligations and notification obligations of unexpected or harmful effects
The decree comes into force on 14 December 2021.
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