+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Procedure Europee per Biocidi

Dossiers and authorisation procedures for biocidal products

The European biocide legislation is directly applicable in all Member States and allows several authorisation procedures: national authorisation, mutual recognition, Union authorisation, and simplified authorisation.

The main services offered in this field are:

  • preliminary evaluation, preparation and submission of a dossier for the authorisation of a biocidal product and assistance in the relevant authorisation procedure
  • identification of studies to be performed (chemical and physical analyses, stability studies, toxicological and ecotoxicological studies, efficacy studies, etc.) according to the Product Type (PT) of interest, the active ingredient and the intended use of the product (e.g. medical area, civil area, etc.)
  • contacts with testing laboratories for test performance
  • preparation and verification of labels of biocidal products in accordance with the current legislation
  • verification of the regulatory provisions on the manufacturing of biocidal products
  • review of advertising texts
  • notification into the Dangerous Preparations database of the High Health Institute (ISS)
  • translations of texts and labels into/from several languages including: Italian, English, Spanish, French, German etc.