Union List

The Union List, as provided for by Regulation (EU) no. 528/2012, records all active ingredients that, after careful assessment at a European level, have been considered suitable for the preparation of biocidal products.

The approval of biocidal substances currently takes place through implementing regulations. It is important to note that the approval of an active substance does not allow the use of the substance for any intended use but it is linked to a specific Product Type (PT), indicated for each active ingredient.

Di Renzo Regulatory Affairs has a dedicated unit made up of regulatory experts in the field of biocides and PMCs (Presidi Medico-Chirurgici, medical surgical aids). We can therefore assist companies in all required activities, including:

• verification of the inclusion of active substances in the Union List
• classification of the product as PMC/biocide/free sale product or otherwise, based on the regulations in force