Regulation on biocides, but there is still a lot to do

Five years elapsed from the date of application of the Biocide regulation, but there is still much to be done both by European authorities and by companies. The review phase of active substances has not concluded yet for the approval of their use in biocide products and many dossiers of products under assessment are still waiting to receive the marketing authorisation.

Moreover, in many European countries a transition phase is going on from the local legislation to the European biocide regulation. In particular, in Italy the provisions of the law on Medical Surgical Aids (Presidi Medico Chirurgici – PMC) that applies to some classes of products containing active substance under review are still valid.

However, not all the classes of products falling into the definition of biocide are included among the PMCs. Therefore, for some products no specific national marketing authorisation is currently required.

The situation will change though, as soon as the active substances are approved for their use in biocides and the products will need to be approved as biocides to stay on the market or be marketed.

On the contrary, some products currently falling into the PMC definition will have no specific position within the European biocide regulation, as they were not considered among the relevant product types.

These include for instance products against lice, that can be classified as PMC or MD, based on their mechanism of action and composition. However, the Italian Ministry of Health has not expressed their opinion officially and has not provided more indications on the position they will take for those products currently classified as PMC.

The situation is therefore quite complex, and involves different norms under continuous evolution. A constant check of the legislation updates and prompt actions are required to stay on the market.